ClinicalTrials.gg
CompletedNCT03408639Updated Dec 18, 2019Results posted

Comparing Efficacy and Safety of CinnaGen Beta Erythropoietin (CinnaPoietin®) Versus Eprex® on the Treatment of Anemia in ESRD Hemodialysis Patients

A Phase 3 interventional study of CinnaPoietin® and Eprex® in Anemia in End-Stage Renal Disease, sponsored by Cinnagen. Completed at 8 sites in Iran, Islamic Republic of. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-12-18.

Sponsored by Cinnagen · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Jun 2016, registered Dec 2017).

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Phase
Phase 3
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 13 studies in Kidney Failure, Chronic with a site in Iran, Islamic Republic of — none open to participants now, none under way, none of them phase 3. Kidney Failure, Chronic · Iran, Islamic Republic of.

Enrollment
3rd of 10
156 · median 77
Started
2016
the only one that year
Phase 3
Only one
of the 13
Registered
8th of 13
by date
Lead sponsor
1 of 13
Cinnagen

Among the 13 studies in Kidney Failure, Chronic with a site in Iran, Islamic Republic of, this one is the 3rd largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2016, is the only one in phase 3, and was the 8th registered.

Kidney Failure, Chronic

2,112 studies on the registry are indexed under Kidney Failure, Chronic; 274 are open to participants now.

Browse Kidney Failure, Chronic studies →

Open to participants now

None of the 13 studies in Kidney Failure, Chronic with a site in Iran, Islamic Republic of is open now. The open studies under Kidney Failure, Chronic, anywhere →

Who these studies take

Of the 169 Kidney Failure, Chronic studies recruiting now, 109 (64%) set no upper age limit and 32 (19%) stop at 75 or younger; 18 take children under 18; 22 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 13 studies in Kidney Failure, Chronic with a site in Iran, Islamic Republic of as a file.
02

Study summary

This Phase III, randomized, two-armed, parallel, double-blind, active-controlled clinical trial is designed to compare efficacy and safety of CinnaPoietin® (Beta erythropoietin) and Eprex® (epoetin alpha) on the treatment of anemia in 156 End-Stage Renal Disease hemodialysis patients. 156 patients have been planned to randomize and assign to receive CinnaPoietin® or Eprex® for a 26-week period. Administration dose for patients who are treated with erythropoietin is the similar dose of the previously administered amount (IV or SC without any change). After then, dose adjustment will be made based on patients' response. The primary objective of this study is to compare the efficacy of CinnaPoietin® with Eprex®. The secondary objectives of this study are further comparison and evaluation of efficacy along with safety between CinnaPoietin® and Eprex®.

Read the detailed description

This study is a phase III, randomized, two-armed, parallel, double-blind (patient and assessor blinded), active-controlled noninferiority clinical trial to determine the non-inferior therapeutic efficacy and safety between CinnaPoietin® (Beta erythropoietin) and Eprex® (epoetin alpha) on the treatment of anemia in ESRD patient under hemodialysis. After signing the written informed consents, 156 patients have been planned to randomize and assign to receive CinnaPoietin® or Eprex® for a 26-weeks period. Administration dose for patients who are treated with erythropoietin is the similar dose of the previously administered amount (IV or SC without any change). After then, dose adjustment will be made based on patients' response. In addition to main intervention, Nephrovit tablet/day and B12 100 mcg/month were prescribed for patients. The primary objective of this study is to compare the efficacy of CinnaPoietin® with Eprex®. The secondary objectives of this study are further comparison and evaluation of efficacy and safety.

The clinical trial will be conducted according to the GCP considerations. A comprehensive validation check program is used to verify the data, and discrepancy reports are generated accordingly for resolution by the investigator.

In order to ensure the use of standard and unified procedure of each test, monitoring of each site and laboratory site are going to be applied by sponsor monitoring team and CRO as external monitoring team.

The same prefilled syringe is used for CinnaPoietin® to be sure that there is no difference between CinnaPoietin® and Eprex® as brand drug. The drugs will be relabeled, and the same label is used for both prefilled syringe. So neither investigators nor subjects are able to notice any differences between them and are blind to the assignment.

Determination of sample size 156 patients will be equally (1:1) divided into intervention arms (78 in each group considering drop out) for achieving 80% power in order to determine non-inferiority using a one-sided, independent sample t-test. The margin of non-inferiority is -1.00.

The true difference between the means is assumed to be -0.500. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 1.200 and 1.200.

03

Conditions studied

  • Anemia in End-Stage Renal Disease

Keywords

  • End-Stage Renal Disease, Anemia, Erythropoietin, Hemoglobin
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged between 18 and 70
  • ESRD patients who are on hemodialysis for ≥3 months.
  • level 8- 11.5 g/dl
  • Patients are on adequate hemodialysis: the minimally adequate dose of hemodialysis given 3 times per week should be a spKt/V (single-pool delivered Kt/V; clearance of urea x dialysis time/volume of distribution) of 1.2 per dialysis. For treatment periods of less than 5 hours, an alternative minimum dose is a urea reduction rate (URR) of 65%. All types of hemodialysis systems and hemodiafiltration, including high-flux membranes are allowed as long as there is no plan to change the patient's regimen during the study.
  • Sufficient iron stores, defined as serum ferritin ≥ 200 ng/ml and transferrin saturation ≥20%. (Patients not meeting these criteria may receive iron supplementation therapy during the Screening and stabilization period to appropriately correct their iron store deficiency to meet the criterion required for randomization);
  • Ability to comply with study medication use, study visits, and study procedures as judged by the investigator;
  • Females of agree to use an acceptable method of (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD) for the duration of the study.
  • Qualified and willing to sign the form with the commitment of complying with all the scheduled visits, and study procedures as judged by the investigator;
  • In any circumstances that potential participants are not able to give consent, it may be given by responsible parents or guardian.

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled hypertension (defined as pre-dialysis diastolic blood pressure ≥ 100 mmHg or systolic blood pressure ≥180 mmHg);
  • Anemia secondary to other causes different to the CKD (e.g. multiple myeloma, aplastic anemia, leukemia;....)
  • Decompensated liver failure;
  • Clinical evidence of concurrent uncontrolled hyperparathyroidism (defined as serum parathyroid hormone (iPTH) > 800 pg/ml);
  • Heart failure [ (NYHA) class III and IV];
  • Unstable angina pectoris, active cardiac disease, stroke and/or cardiac infarction within the last 6 months;
  • History of or active blood coagulation disorders including DVT, PTE, native access Thrombosis during last 6 months.
  • Thrombocytosis ( count > 500,000/µl);
  • Thrombocytopenia (platelet count \< 100,000/µl);
  • White blood cell count \< 3,000/µl);
  • White blood cell count >15,000/µl)
  • Recent Bleeding (acute or chronic bleeding within three months prior to screening);
  • Suspicion of or confirmed occult bleeding (increased reticulocyte count);
  • Clinical evidence of concurrent systemic infection, or inflammatory disease (e.g; diabetic foot, bed sore, access infection, CRP> 30 mg/l,...)
  • Currently receiving treatment for epilepsy;
  • Major surgery within 3 months prior to randomization and during the conduct of the trial (except vascular access surgery);
  • Concomitant therapy; patients on a short course of (up to 7 days), topical or intranasal steroids are allowed in the study;
  • History of any malignant disease within the last 5 years (except excised non-melanoma skin cancer);
  • Women who are pregnant or breastfeeding;
  • Known history of severe drug-related allergies;
  • Known history of drug related allergy to Erythropoietin or one of the ingredients of the test or the reference products or to mammalian-derived products;
  • Transplant received within one year prior to the start of the study;
  • Simultaneous participation in another clinical study or having received an Medicinal Product within three months before randomization in this study.
  • Psychiatric, addictive (drugs or alcohol) or any other disorder that compromises the ability to give an ;
  • Any red blood cell transfusion during the last 3 months (measured at the time of eligibility verification);
  • Primary hematological disorder (e.g. myelodysplastic syndrome, myeloma, sickle cell anemia, hematological , multiple myeloma hemolytic anemia);
  • known resistance to the rHuEPO defined by a requirement > 450 IU/kg/week by IV or 300 IU/kg/week by SC, equivalent to approximately 20.000 IU/week SC and in absence of iron deficiency;
  • who have suffered an event of active bleeding in the 30 days prior to the beginning of the study;
  • Morbid obesity, defined by a (BMI) > 37 kg/m2 in women and > 40 kg/m2 in men.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
156 participants (actual)

Study arms

  • Experimental
    CinnaPoietin®

    The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.

    Drug: CinnaPoietin® · Drug: Nephrovit · Drug: Vitamin B12 Injection

  • Active comparator
    Eprex®

    The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.

    Drug: Eprex® · Drug: Nephrovit · Drug: Vitamin B12 Injection

Interventions

  • DrugCinnaPoietin®

    The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.

    Also known as: Beta erythropoietin

  • The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.

    Also known as: Epoetin alpha

  • DrugNephrovit

    Nephrovit tablet is daily administered to all the patients.

  • Vitamin B12 is monthly injected to all the patients.

06

What researchers measure

Primary outcomes

  1. Mean Hb Change Level During the Last Four Weeks of Treatment

    The primary endpoints of this study is to assess mean Hb change level during the last four weeks of treatment.

    Time frame: Week 22 to week 26

  2. Mean Weekly Epoetin Dosage Per kg Body Weight During the Last Four Weeks of Treatment

    The mean weekly epoetin dosage per kg body weight during the last four weeks of treatment necessary to maintain the Hb level within 10-12 g/dl during the last four weeks of treatment is considered as the second primary endpoint.

    Time frame: Week 22 to week 26

Secondary outcomes

  1. The Proportion of Patients With Any Permanent or Transient Dose Change

    The proportion of patients with any permanent or transient dose change during 26 weeks.

    Time frame: 26 weeks

  2. The Proportion of Patients With Any Hb Measurement Outside the Target Range (10-12 g/dl)

    The proportion of patients with any Hb measurement outside the target range (10-12 g/dl) during 26 weeks.

    Time frame: 26 weeks

  3. The Proportion of Patients Needed Blood Transfusions

    The proportion of patients needed blood transfusions during 26 weeks.

    Time frame: 26 weeks

  4. The Proportion of Patients With Treatment Success

    Treatment success is considered as Hb concentration equal to or more than 11.0 g/dl and two consecutive weeks without any blood transfusion within the preceding three months

    Time frame: Week 12 to week 26

  5. The Proportion of Patients With Maintenance Success

    Maintenance success is considered as maintenance success is considered as maintenance of mean Hb concentration of 11.0 ± 1.0 g/dl for at least four consecutive weeks

    Time frame: 26 weeks

  6. The Percentage of Patients With Hb Measurements More Than 10.0 g/dl

    The percentage of patients with Hb measurements more than 10.0 g/dl from week 22 to week 26.

    Time frame: Week 22 to week 26

  7. The Percentage of Patients With Hematocrit Measurements More Than 30%

    The percentage of patients with hematocrit measurements more than 30% from week 22 to week 26.

    Time frame: Week 22 to week 26

  8. The Incidence of Hb Levels Above 13 g/dl

    The first safety endpoint is the proportion of patients with at least one Hb measurement above 13 g/dL.

    Time frame: 26 weeks

  9. The Proportion of Patients With an Increase in Hb Concentration of > 1.0 g/dl for Four Consecutive Weeks

    The proportion of patients with an increase in Hb concentration of \> 1.0 g/dl for four consecutive weeks during 26 weeks.

    Time frame: 26 weeks

  10. The Incidence of Adverse Events

    The incidence of adverse events during 26 weeks.

    Time frame: 26 weeks

07

Results

Posted Nov 6, 2019

Participant flow

Participant flow — Overall Study
MilestoneCinnaPoietin®Eprex®
Started7878
Completed6756
Not completed1122
Withdrew: Death55
Withdrew: Lost to follow-up14
Withdrew: Withdrawal by subject27
Withdrew: Physician decision36

Outcome measures

PrimaryMean Hb Change Level During the Last Four Weeks of Treatment

The primary endpoints of this study is to assess mean Hb change level during the last four weeks of treatment.

Time frame:
Week 22 to week 26
Reported as:
Mean · g/dL
Mean Hb Change Level During the Last Four Weeks of Treatment
g/dLCinnaPoietin®Eprex®
Mean Hb Change Level During the Last Four Weeks of Treatment0.4 ± 1.260.74 ± 1.39
PrimaryMean Weekly Epoetin Dosage Per kg Body Weight During the Last Four Weeks of Treatment

The mean weekly epoetin dosage per kg body weight during the last four weeks of treatment necessary to maintain the Hb level within 10-12 g/dl during the last four weeks of treatment is considered as the second primary endpoint.

Time frame:
Week 22 to week 26
Reported as:
Mean · IU/Kg/week
Mean Weekly Epoetin Dosage Per kg Body Weight During the Last Four Weeks of Treatment
IU/Kg/weekCinnaPoietin®Eprex®
Mean Weekly Epoetin Dosage Per kg Body Weight During the Last Four Weeks of Treatment117.02 ± 54.5110.01 ± 49.27
SecondaryThe Proportion of Patients With Any Permanent or Transient Dose Change

The proportion of patients with any permanent or transient dose change during 26 weeks.

Time frame:
26 weeks
Reported as:
Number · proportion of patients
The Proportion of Patients With Any Permanent or Transient Dose Change
proportion of patientsCinnaPoietin®Eprex®
The Proportion of Patients With Any Permanent or Transient Dose Change0.90.95
SecondaryThe Proportion of Patients With Any Hb Measurement Outside the Target Range (10-12 g/dl)

The proportion of patients with any Hb measurement outside the target range (10-12 g/dl) during 26 weeks.

Time frame:
26 weeks
Reported as:
Number · proportion of patients
The Proportion of Patients With Any Hb Measurement Outside the Target Range (10-12 g/dl)
proportion of patientsCinnaPoietin®Eprex®
The Proportion of Patients With Any Hb Measurement Outside the Target Range (10-12 g/dl)0.921
SecondaryThe Proportion of Patients Needed Blood Transfusions

The proportion of patients needed blood transfusions during 26 weeks.

Time frame:
26 weeks
Reported as:
Number · proportion of patients
The Proportion of Patients Needed Blood Transfusions
proportion of patientsCinnaPoietin®Eprex®
The Proportion of Patients Needed Blood Transfusions0.040.04
SecondaryThe Proportion of Patients With Treatment Success

Treatment success is considered as Hb concentration equal to or more than 11.0 g/dl and two consecutive weeks without any blood transfusion within the preceding three months

Time frame:
Week 12 to week 26
Reported as:
Number · proportion of patients
The Proportion of Patients With Treatment Success
proportion of patientsCinnaPoietin®Eprex®
The Proportion of Patients With Treatment Success0.410.44
SecondaryThe Proportion of Patients With Maintenance Success

Maintenance success is considered as maintenance success is considered as maintenance of mean Hb concentration of 11.0 ± 1.0 g/dl for at least four consecutive weeks

Time frame:
26 weeks
Reported as:
Number · proportion of patients
The Proportion of Patients With Maintenance Success
proportion of patientsCinnaPoietin®Eprex®
The Proportion of Patients With Maintenance Success0.710.43
SecondaryThe Percentage of Patients With Hb Measurements More Than 10.0 g/dl

The percentage of patients with Hb measurements more than 10.0 g/dl from week 22 to week 26.

Time frame:
Week 22 to week 26
Reported as:
Count of participants · Participants
The Percentage of Patients With Hb Measurements More Than 10.0 g/dl
ParticipantsCinnaPoietin®Eprex®
The Percentage of Patients With Hb Measurements More Than 10.0 g/dl5548
SecondaryThe Percentage of Patients With Hematocrit Measurements More Than 30%

The percentage of patients with hematocrit measurements more than 30% from week 22 to week 26.

Time frame:
Week 22 to week 26
Reported as:
Number · percentage of patients
The Percentage of Patients With Hematocrit Measurements More Than 30%
percentage of patientsCinnaPoietin®Eprex®
The Percentage of Patients With Hematocrit Measurements More Than 30%86.7692.86
SecondaryThe Incidence of Hb Levels Above 13 g/dl

The first safety endpoint is the proportion of patients with at least one Hb measurement above 13 g/dL.

Time frame:
26 weeks
Reported as:
Count of participants · Participants
The Incidence of Hb Levels Above 13 g/dl
ParticipantsCinnaPoietin®Eprex®
The Incidence of Hb Levels Above 13 g/dl3142
SecondaryThe Proportion of Patients With an Increase in Hb Concentration of > 1.0 g/dl for Four Consecutive Weeks

The proportion of patients with an increase in Hb concentration of \> 1.0 g/dl for four consecutive weeks during 26 weeks.

Time frame:
26 weeks
Reported as:
Count of participants · Participants
The Proportion of Patients With an Increase in Hb Concentration of > 1.0 g/dl for Four Consecutive Weeks
ParticipantsCinnaPoietin®Eprex®
The Proportion of Patients With an Increase in Hb Concentration of > 1.0 g/dl for Four Consecutive Weeks4441
SecondaryThe Incidence of Adverse Events

The incidence of adverse events during 26 weeks.

Time frame:
26 weeks
Reported as:
Count of participants · Participants
The Incidence of Adverse Events
ParticipantsCinnaPoietin®Eprex®
The Incidence of Adverse Events2318

Adverse events

Collected over 26 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CinnaPoietin®5/78 (6.4%)14/78 (17.9%)11/78 (14.1%)
Eprex®5/78 (6.4%)7/78 (9%)12/78 (15.4%)
Most frequent serious events
Most frequent serious events
EventCinnaPoietin®Eprex®
(Skin reaction, Catheter defect, Disability catheter, Filter clots, pain in injection site, skin reaGeneral disorders4/780/78
Palpitation, Cardiac Function Impairment, Cardiac Infraction, Chest Pain, Tachycardia)Cardiac disorders2/783/78
(Pneumonia, Infection of right hand Lower than the fistula)Infections and infestations2/780/78
(CO toxicity, transplantation complication)Injury, poisoning and procedural complications0/782/78
(tearing of tendon in both knees, back pain, Musculoskeletal-Bone pain, knee tenderness due to jointMusculoskeletal and connective tissue disorders2/781/78
Inflation on AnkleRenal and urinary disorders1/780/78
GallstonesHepatobiliary disorders1/780/78
(Respiratory disorder, chest pain and dyspenea, dyspnea)Respiratory, thoracic and mediastinal disorders1/780/78
echymosis due to recent car accident, itching)Skin and subcutaneous tissue disorders0/781/78
Cardiac pacemaker AND Valve Replacement, orthopedic surgery)Surgical and medical procedures1/780/78
Most frequent other events
Showing 10 of 13
Most frequent other events
EventCinnaPoietin®Eprex®
(Palpitation, Cardiac Function Impairment, Cardiac Infraction, Chest Pain, Tachycardia)Cardiac disorders1/783/78
(Skin reaction, Catheter defect, Disability catheter, Filter clots, pain in injection site, skin reaGeneral disorders3/781/78
(Respiratory disorder, chest pain and dyspenea, dyspnea)Respiratory, thoracic and mediastinal disorders2/780/78
(itching, echymosis due to recent car accident, itching)Skin and subcutaneous tissue disorders0/782/78
(blood clotting, Bleeding catheter, Hemorrage, Vascular disorders)Vascular disorders2/780/78
(Eosinophilia, Thrombocytopenia)Blood and lymphatic system disorders0/781/78
(Pneumonia, Infection of right hand Lower than the fistula)Infections and infestations1/780/78
HyperkalemiaMetabolism and nutrition disorders0/781/78
(tearing of tendon in both knees, back pain, Musculoskeletal-Bone pain, knee tenderness due to jointMusculoskeletal and connective tissue disorders0/781/78
(numbness in the wrist, dizziness)Nervous system disorders1/781/78

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)CinnaPoietin®Eprex®Total
<=18 years000
Between 18 and 65 years6069129
>=65 years18927
Age, Continuous
Age, Continuous(years)CinnaPoietin®Eprex®Total
Mean55.02 ± 11.3850.01 ± 12.7252.53 ± 12.28
Sex: Female, Male
Sex: Female, Male(Participants)CinnaPoietin®Eprex®Total
Female333366
Male454590
Race (NIH/OMB)
Race (NIH/OMB)(Participants)CinnaPoietin®Eprex®Total
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White7878156
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)CinnaPoietin®Eprex®Total
Iran7878156
Hemoglobin concentration
Hemoglobin concentration(g/dL)CinnaPoietin®Eprex®Total
Mean10.41 ± 0.8910.64 ± 0.8210.53 ± 0.86
08

Study locations

8 sites
  • Javad-al-Aemeh clinic
    Kerman, Iran, Islamic Republic of
  • SHAFA Hospital
    Kerman, Iran, Islamic Republic of
  • Haj Ebrahimi dialysis center
    Shiraz, Iran, Islamic Republic of
  • Ghiasi hospital
    Tehran, Iran, Islamic Republic of
  • Hashemi Nezhad Hospital
    Tehran, Iran, Islamic Republic of
  • Imam Hussein Hospital
    Tehran, Iran, Islamic Republic of
  • Madar dialysis center
    Tehran, Iran, Islamic Republic of
  • Milad Hospital
    Tehran, Iran, Islamic Republic of
09

References and documents

Publications

  • Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (1988-1994). Arch Intern Med. 2002 Jun 24;162(12):1401-8. doi: 10.1001/archinte.162.12.1401. PubMed 12076240 ↗
  • McLean E, Cogswell M, Egli I, Wojdyla D, de Benoist B. Worldwide prevalence of anaemia, WHO Vitamin and Mineral Nutrition Information System, 1993-2005. Public Health Nutr. 2009 Apr;12(4):444-54. doi: 10.1017/S1368980008002401. Epub 2008 May 23. PubMed 18498676 ↗
  • Brittin GM, Brecher G, Johnson CA, Elashoff RM. Stability of blood in commonly used anticoagulants. Use of refrigerated blood for quality control of the Coulter Counter Model S. Am J Clin Pathol. 1969 Dec;52(6):690-4. doi: 10.1093/ajcp/52.6.690. No abstract available. PubMed 4982112 ↗
  • Locatelli F, Aljama P, Barany P, Canaud B, Carrera F, Eckardt KU, Horl WH, Macdougal IC, Macleod A, Wiecek A, Cameron S; European Best Practice Guidelines Working Group. Revised European best practice guidelines for the management of anaemia in patients with chronic renal failure. Nephrol Dial Transplant. 2004 May;19 Suppl 2:ii1-47. doi: 10.1093/ndt/gfh1032. No abstract available. PubMed 15206425 ↗
  • Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available. PubMed 15758012 ↗
  • Fehr T, Ammann P, Garzoni D, Korte W, Fierz W, Rickli H, Wuthrich RP. Interpretation of erythropoietin levels in patients with various degrees of renal insufficiency and anemia. Kidney Int. 2004 Sep;66(3):1206-11. doi: 10.1111/j.1523-1755.2004.00880.x. PubMed 15327419 ↗
  • Ross RP, McCrea JB, Besarab A. Erythropoietin response to blood loss in hemodialysis patients in blunted but preserved. ASAIO J. 1994 Jul-Sep;40(3):M880-5. doi: 10.1097/00002480-199407000-00122. PubMed 8555638 ↗
  • Lipschitz DA, Cook JD, Finch CA. A clinical evaluation of serum ferritin as an index of iron stores. N Engl J Med. 1974 May 30;290(22):1213-6. doi: 10.1056/NEJM197405302902201. No abstract available. PubMed 4825851 ↗
  • Rambod M, Kovesdy CP, Kalantar-Zadeh K. Combined high serum ferritin and low iron saturation in hemodialysis patients: the role of inflammation. Clin J Am Soc Nephrol. 2008 Nov;3(6):1691-701. doi: 10.2215/CJN.01070308. Epub 2008 Oct 15. PubMed 18922994 ↗
  • Fernandez-Rodriguez AM, Guindeo-Casasus MC, Molero-Labarta T, Dominguez-Cabrera C, Hortal-Casc n L, Perez-Borges P, Vega-Diaz N, Saavedra-Santana P, Palop-Cubillo L. Diagnosis of iron deficiency in chronic renal failure. Am J Kidney Dis. 1999 Sep;34(3):508-13. doi: 10.1016/s0272-6386(99)70079-x. PubMed 10469862 ↗
  • Kalantar-Zadeh K, Hoffken B, Wunsch H, Fink H, Kleiner M, Luft FC. Diagnosis of iron deficiency anemia in renal failure patients during the post-erythropoietin era. Am J Kidney Dis. 1995 Aug;26(2):292-9. doi: 10.1016/0272-6386(95)90649-5. PubMed 7645533 ↗
  • Aljama P, Ward MK, Pierides AM, Eastham EJ, Ellis HA, Feest TG, Conceicao S, Kerr DN. Serum ferritin concentration: a reliable guide to iron overload in uremic and hemodialyzed patients. Clin Nephrol. 1978 Sep;10(3):101-4. PubMed 699405 ↗
  • Barany P, Eriksson LC, Hultcrantz R, Pettersson E, Bergstrom J. Serum ferritin and tissue iron in anemic dialysis patients. Miner Electrolyte Metab. 1997;23(3-6):273-6. PubMed 9387132 ↗
  • Blumberg AB, Marti HR, Graber CG. Serum ferritin and bone marrow iron in patients undergoing continuous ambulatory peritoneal dialysis. JAMA. 1983 Dec 23-30;250(24):3317-9. PubMed 6645029 ↗
  • Hussein S, Prieto J, O'Shea M, Hoffbrand AV, Baillod RA, Moorhead JF. Serum ferritin assay and iron status in chronic renal failure and haemodialysis. Br Med J. 1975 Mar 8;1(5957):546-8. doi: 10.1136/bmj.1.5957.546. PubMed 49205 ↗
  • Mirahmadi KS, Paul WL, Winer RL, Dabir-Vaziri N, Byer B, Gorman JT, Rosen SM. Serum ferritin level. Determinant of iron requirement in hemodialysis patients. JAMA. 1977 Aug 15;238(7):601-3. doi: 10.1001/jama.238.7.601. PubMed 577960 ↗
  • Spinowitz BS, Kausz AT, Baptista J, Noble SD, Sothinathan R, Bernardo MV, Brenner L, Pereira BJ. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol. 2008 Aug;19(8):1599-605. doi: 10.1681/ASN.2007101156. Epub 2008 Jun 4. PubMed 18525001 ↗
  • Silverberg DS, Blum M, Agbaria Z, Deutsch V, Irony M, Schwartz D, Baruch R, Yachnin T, Steinbruch S, Iaina A. The effect of i.v. iron alone or in combination with low-dose erythropoietin in the rapid correction of anemia of chronic renal failure in the predialysis period. Clin Nephrol. 2001 Mar;55(3):212-9. PubMed 11316241 ↗
  • Stancu S, Barsan L, Stanciu A, Mircescu G. Can the response to iron therapy be predicted in anemic nondialysis patients with chronic kidney disease? Clin J Am Soc Nephrol. 2010 Mar;5(3):409-16. doi: 10.2215/CJN.04280609. Epub 2009 Dec 17. Erratum In: Clin J Am Soc Nephrol. 2010 Nov;5(11):2137-8. PubMed 20019121 ↗
  • Fishbane S, Frei GL, Maesaka J. Reduction in recombinant human erythropoietin doses by the use of chronic intravenous iron supplementation. Am J Kidney Dis. 1995 Jul;26(1):41-6. doi: 10.1016/0272-6386(95)90151-5. PubMed 7611266 ↗
  • Sunder-Plassmann G, Horl WH. Importance of iron supply for erythropoietin therapy. Nephrol Dial Transplant. 1995 Nov;10(11):2070-6. PubMed 8643170 ↗
  • Macdougall IC, Tucker B, Thompson J, Tomson CR, Baker LR, Raine AE. A randomized controlled study of iron supplementation in patients treated with erythropoietin. Kidney Int. 1996 Nov;50(5):1694-9. doi: 10.1038/ki.1996.487. PubMed 8914038 ↗
  • Chang CH, Chang CC, Chiang SS. Reduction in erythropoietin doses by the use of chronic intravenous iron supplementation in iron-replete hemodialysis patients. Clin Nephrol. 2002 Feb;57(2):136-41. doi: 10.5414/cnp57136. PubMed 11863124 ↗
  • DeVita MV, Frumkin D, Mittal S, Kamran A, Fishbane S, Michelis MF. Targeting higher ferritin concentrations with intravenous iron dextran lowers erythropoietin requirement in hemodialysis patients. Clin Nephrol. 2003 Nov;60(5):335-40. doi: 10.5414/cnp60335. PubMed 14640239 ↗
  • Rozen-Zvi B, Gafter-Gvili A, Paul M, Leibovici L, Shpilberg O, Gafter U. Intravenous versus oral iron supplementation for the treatment of anemia in CKD: systematic review and meta-analysis. Am J Kidney Dis. 2008 Nov;52(5):897-906. doi: 10.1053/j.ajkd.2008.05.033. Epub 2008 Oct 8. PubMed 18845368 ↗
  • Senger JM, Weiss RJ. Hematologic and erythropoietin responses to iron dextran in the hemodialysis environment. ANNA J. 1996 Jun;23(3):319-23; discussion 324-5. PubMed 8716991 ↗
  • Navarro JF, Teruel JL, Liano F, Marcen R, Ortuno J. Effectiveness of intravenous administration of Fe-gluconate-Na complex to maintain adequate body iron stores in hemodialysis patients. Am J Nephrol. 1996;16(4):268-72. doi: 10.1159/000169008. PubMed 8739277 ↗
  • Tessitore N, Solero GP, Lippi G, Bassi A, Faccini GB, Bedogna V, Gammaro L, Brocco G, Restivo G, Bernich P, Lupo A, Maschio G. The role of iron status markers in predicting response to intravenous iron in haemodialysis patients on maintenance erythropoietin. Nephrol Dial Transplant. 2001 Jul;16(7):1416-23. doi: 10.1093/ndt/16.7.1416. PubMed 11427634 ↗
  • Van Wyck DB, Roppolo M, Martinez CO, Mazey RM, McMurray S; United States Iron Sucrose (Venofer) Clinical Trials Group. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int. 2005 Dec;68(6):2846-56. doi: 10.1111/j.1523-1755.2005.00758.x. PubMed 16316362 ↗
  • Allegra V, Mengozzi G, Vasile A. Iron deficiency in maintenance hemodialysis patients: assessment of diagnosis criteria and of three different iron treatments. Nephron. 1991;57(2):175-82. doi: 10.1159/000186246. PubMed 1902285 ↗
  • Li H, Wang SX. Intravenous iron sucrose in Chinese hemodialysis patients with renal anemia. Blood Purif. 2008;26(2):151-6. doi: 10.1159/000113529. Epub 2008 Jan 22. PubMed 18212498 ↗
  • Palmer SC, Navaneethan SD, Craig JC, Johnson DW, Tonelli M, Garg AX, Pellegrini F, Ravani P, Jardine M, Perkovic V, Graziano G, McGee R, Nicolucci A, Tognoni G, Strippoli GF. Meta-analysis: erythropoiesis-stimulating agents in patients with chronic kidney disease. Ann Intern Med. 2010 Jul 6;153(1):23-33. doi: 10.7326/0003-4819-153-1-201007060-00252. Epub 2010 Jun 24. PubMed 20439566 ↗
  • Parfrey PS, Wish T. Quality of life in CKD patients treated with erythropoiesis-stimulating agents. Am J Kidney Dis. 2010 Mar;55(3):423-5. doi: 10.1053/j.ajkd.2009.12.014. No abstract available. PubMed 20189050 ↗
  • Gandra SR, Finkelstein FO, Bennett AV, Lewis EF, Brazg T, Martin ML. Impact of erythropoiesis-stimulating agents on energy and physical function in nondialysis CKD patients with anemia: a systematic review. Am J Kidney Dis. 2010 Mar;55(3):519-34. doi: 10.1053/j.ajkd.2009.09.019. Epub 2009 Dec 23. PubMed 20031287 ↗
  • Johansen KL, Finkelstein FO, Revicki DA, Gitlin M, Evans C, Mayne TJ. Systematic review and meta-analysis of exercise tolerance and physical functioning in dialysis patients treated with erythropoiesis-stimulating agents. Am J Kidney Dis. 2010 Mar;55(3):535-48. doi: 10.1053/j.ajkd.2009.12.018. Epub 2010 Feb 4. PubMed 20133033 ↗
  • Solomon SD, Uno H, Lewis EF, Eckardt KU, Lin J, Burdmann EA, de Zeeuw D, Ivanovich P, Levey AS, Parfrey P, Remuzzi G, Singh AK, Toto R, Huang F, Rossert J, McMurray JJ, Pfeffer MA; Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) Investigators. Erythropoietic response and outcomes in kidney disease and type 2 diabetes. N Engl J Med. 2010 Sep 16;363(12):1146-55. doi: 10.1056/NEJMoa1005109. PubMed 20843249 ↗
  • Azmandian J, Abbasi MR, Pourfarziani V, Nasiri AA, Ossareh S, Ezzatzadegan Jahromi S, Sanadgol H, Amini S, Shahvaroughi Farahani A. Comparing Therapeutic Efficacy and Safety of Epoetin Beta and Epoetin Alfa in the Treatment of Anemia in End-Stage Renal Disease Hemodialysis Patients. Am J Nephrol. 2018;48(4):251-259. doi: 10.1159/000493097. Epub 2018 Sep 25. PubMed 30253403 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2016 to primary completion in Jul 2017, 12 months.

Results were first posted in Nov 2019, 2 years 3 months after primary completion.

Of 42 industry-sponsored phase 3 interventional studies under Kidney Failure, Chronic, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 40. This study's 12 months is below that.

Counting every sponsor, half of 66 studies reached it within 32 months; a quarter within 21 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2017
First posted
Jan 24, 2018
StartActual
Jun 22, 2016
Primary completionActual
Jul 19, 2017
CompletionActual
Jul 19, 2017
Results first posted
Nov 6, 2019
Last update
Dec 18, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03408639
Lead sponsor
Cinnagen
Responsible party
Sponsor
First posted
Jan 24, 2018
Start date
Jun 22, 2016
Primary completion
Jul 19, 2017
Completion
Jul 19, 2017
Results posted
Nov 6, 2019
Last update
Dec 18, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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