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CompletedNCT02134314C1INHDGFUpdated Jun 25, 2018Results posted

C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI

A Phase 1/2 interventional study of C1 Esterase Inhibitor and Placebo in End Stage Renal Disease, Kidney Failure and Delayed Graft Function, sponsored by Cedars-Sinai Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-06-25.

Sponsored by Cedars-Sinai Medical Center · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The use of C1INH (Berinert) in patients receiving deceased donor kidney transplants with high risk for delayed graft function (DGF) may show significant improvement in outcomes post transplant compared with patients that do not receive C1INH treatment. Complement activation has been detected in animal models and human kidneys with ischemic reperfusion injury (IRI) and inflammatory cell infiltrates. By blocking complement activation the investigators hope to improve kidney graft function post transplant in these recipients.

Read the detailed description

Early graft function has a long-term effect on graft survival. Poor early graft function and delayed graft function (DGF) contributes to decreased short- and long-term patient and graft survival, increased incidence of acute rejection, prolonged hospitalization, and higher costs of transplantation. Although multiple factors contribute to the impaired graft function, ischemia-reperfusion injury (IRI) is the underlying pathophysiology leading to poor early graft function and DGF. A >35% incidence of DGF has remained constant over time despite significant improvements in immunosuppressive strategies and patient management. This may be due to increased use of kidneys from "extended-criteria" and/or non-heart-beating donors, where even greater rates (>60%) of DGF have been reported.

More than 96,680 people are currently waiting for a kidney transplant in the United States (United Network for Organ Sharing (UNOS); UNOS.org 3/22/13). Of the 15,092 kidney transplants performed in the US in 2011, \~11,000 (62%) were from deceased donors. Of these, approximately 17% were from expanded-criteria donors. The USRDS reports that more than 50% of patients on the waiting list are willing to accept a kidney from an expanded-criteria donor (ECD) or donors after cardiac death (DCD).

From the investigators previous studies with C1INH (Berinert®) for prevention of antibody mediated rejection (ABMR), the investigators noted that no patients developed ABMR during treatment with C1INH, the investigators also noted a near significant reduction in DGF due to IRI (ClinicalTrials.gov(NCT01134510), FDA Investigational New Drug (IND#): 14363). These findings suggest an important role for complement in the mediation of IRI and that inhibition of early complement activation using C1INH in patients receiving at risk kidneys for IRI should reduce this costly and often devastating complication of kidney transplantation. In addition, numerous other studies in animal models have shown dramatic improvements in IRI models with the use of C1INH. Complement activation is detectable in animal and in human kidneys models after IRI and experimental data suggests that use of C1INH prior to induction of IRI significantly reduces IRI as well as inflammatory cell infiltrates. Based on this, the investigators hypothesize that the use of C1INH in patients receiving deceased donor (DD) kidney transplants with high risk for DGF will show significant reductions in DGF and improved outcomes post-transplant compared with patients receiving DD transplants who do not receive C1INH treatment. Here, the investigators propose to investigate the application of pre-operative and post-transplant doses of C1INH (Berinert®) vs. placebo in adult subjects receiving a DD renal allograft considered at high-risk for IRI and DGF. The investigators hypothesize that C1INH treated patients will demonstrate improved function of the kidney allograft compared to placebo, with equivalence in safety. The primary objectives of this study are: Using a double blinded, placebo controlled format, the investigators will:

  1. Evaluate and compare the safety of C1INH (50 units/kilogram, round to the nearest 500 unit) administered pre-transplant and 24 hrs post-transplant in recipients of kidney allografts from high risk for IRI deceased donors.

The secondary objectives are to:

  1. On the basis of safety and efficacy, determine appropriate Berinert® study dose for Phase III investigation, and
  2. Determine appropriate endpoint choice for Phase III investigation.
02

Conditions studied

  • End Stage Renal Disease
  • Kidney Failure
  • Delayed Graft Function
  • Ischemic Reperfusion Injury

Keywords

  • ESRD (End Stage Renal Disease)
  • CKD (Chronic Kidney Disease)
  • Kidney Transplant
  • ECD
  • delayed graft function
  • chronic kidney disease
  • expanded-criteria donor
  • end stage renal disease
03

In context

Kidney Failure, Chronic

2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.

This study's enrollment of 70 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 456 studies on the registry; 107 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.

Browse Cedars-Sinai Medical Center studies →

Counted across the registry records on this site, refreshed daily.

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

  • 18-70 yrs of age; recipient of ECD/DCD/ECD\&DCD with risk index 3-8 for DGF based on specific criteria
  • recipient who are ABO compatible with donor allograft
  • pretransplant with meningococcal vaccination
  • understand and sign a written consent prior to any study specific procedure.

Risk index (minimum 3- maximum 8):

DGF scale: Donor Age (\<40yr = 0, 41-49yr = 1, 50-54yr = 2, 55-59yr = 3, >60yr=6), Cold Ischemia Time (0-12= 0, 13-18=1, 19-24=2, 24-30=3, 31-36=4, >37=6; Recipient Race (nonblack = 0, black =1); Donor death due to Cerebrovascular Accident (CVA) (donor age \<50yrs = 0, donor age >50yrs = 3).

Exclusion criteria

Exclusion Criteria:

  • patients with known prothrombotic disorder (e.g. factor V leiden)
  • history of thrombosis or hypercoagulable state excluding access clotting
  • history of administration of C1INH containing products or recombinant C1INH within 15 days prior to study entry
  • patients with known to treatment with C1INH
  • patients with abnormal coagulation function ( >2, partial thromboplastin time (PTT) > 50, \<80,000)
  • who are not on anti-coagulation
  • patients with known active presence of
  • Polymerase chain reaction (PCR) positive for hep B/hep C/or
  • preemptive kidney transplantation recipient
  • recipients of multi-organ transplants (kidney and any other organ)
  • recipients of kidney allograft from DD who: cold ischemia time (CIT) \<18h, terminal serum creatinine \</= 1mg/dl, recipient of kidney allograft that was on pump preservation for any period prior to transplantation, recipient of kidney allograft from a living donor, female subject who are pregnant or lactating.
Terms in these criteria, in plain language(5)

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

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.

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.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    C1-Inhibitor (Berinert) (Human) (C1INH)

    35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.

    Drug: C1 Esterase Inhibitor

  • Placebo comparator
    Normal Saline

    35 patients will receive placebo in addition to standard of care immunosuppressive therapy.

    Drug: Placebo

Interventions

  • DrugC1 Esterase Inhibitor

    C1 Esterase Inhibitor 50 units per kilogram intravenous infusion administered on day of transplant, and another dose at 24 hours post-operatively. Total: 2 doses

    Also known as: Berinert (C1INH)

  • DrugPlacebo

    Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose at 24 hours post-operatively. Total: 2 doses

    Also known as: Normal Saline (0.9%NaCl)

06

What researchers measure

Primary outcomes

  1. Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5.

    Number of participants in the C1INH and placebo groups with serum creatinine \>3mg/dL on postoperative day 5

    Time frame: First 7 days post-transplant

  2. Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant.

    The proportion of patients enrolled who require at least one session of dialysis in the first 7 days post transplant (excluding those who are dialyzed for hyperkalemia).

    Time frame: First 7 days post-transplant

  3. Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant.

    Number of patients in the C1INH and placebo groups with serum creatinine reduction of \< 30% from 24 to 48 hours post-transplant.

    Time frame: First 7 days post-transplant

  4. Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant.

    Mean quantity of dialysis sessions per patient in the first 7 days post transplant.

    Time frame: First 7 days post-transplant

Secondary outcomes

  1. Serum Creatinine

    Mean serum creatinine on day 90 in mg/dL

    Time frame: Up to 90 days post-transplant

  2. Creatinine Clearance

    Creatinine clearance calculated based on serum creatinine, milliliters per minute.

    Time frame: Up to 90 days post-transplant

  3. 24h Urine Output

    24 hour urine output post-transplantation measured in milliliters

    Time frame: 24 hours post-transplant

  4. Mean Number of Patients on Dialysis

    Mean number of patients on dialysis at 15 to 30 days post-transplant

    Time frame: 15 to 30 days post-transplantation

  5. Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale)

    DGF Scale: Grade 1 - immediate urine production and no need for dialysis with creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation \>70% Grade 2 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of \>70% with need for dialysis Grade 3 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation \<70% with no need for dialysis Grade 4 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of \<70% with need for dialysis.

    Time frame: First 7 days post-transplant

Other outcomes

  1. Overall Incidence of Serious Adverse Events

    Overall incidence of serious adverse events in the C1INH and placebo groups, number of events.

    Time frame: Up to 9 months post-transplant

  2. Patient Survival

    Patient survival at 90 days post-transplantation

    Time frame: Up to 90 days post-transplant

  3. Rate of Acute Cellular Rejection (ACR)

    Number of acute cellular and antibody mediated rejection episodes by day 90.

    Time frame: Up to 90 days post-transplant

  4. Graft Survival

    Number of Participants with Graft Survival at 90 Days Post-Transplant

    Time frame: Day 90 Post-transplant

07

Results

Posted Jun 25, 2018
Limitations and caveats
The limitations of this study include the small sample size and single-center performance. However, the patient population was balanced between the two groups and donor organ characteristics, including implantation biopsies, were similar.

Participant flow

Participant flow — Overall Study
MilestoneC1-Inhibitor (Berinert) (Human) (C1INH)Normal Saline
Started3535
Completed3434
Not completed11

Outcome measures

PrimaryNumber of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5.

Number of participants in the C1INH and placebo groups with serum creatinine \>3mg/dL on postoperative day 5

Time frame:
First 7 days post-transplant
Reported as:
Count of participants · Participants
Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5.
ParticipantsC1-Inhibitor (Berinert) (Human) (C1INH)Normal Saline
Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5.2932
PrimaryNumber of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant.

The proportion of patients enrolled who require at least one session of dialysis in the first 7 days post transplant (excluding those who are dialyzed for hyperkalemia).

Time frame:
First 7 days post-transplant
Reported as:
Count of participants · Participants
Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant.
ParticipantsC1-Inhibitor (Berinert) (Human) (C1INH)Normal Saline
Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant.1521
PrimaryNumber of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant.

Number of patients in the C1INH and placebo groups with serum creatinine reduction of \< 30% from 24 to 48 hours post-transplant.

Time frame:
First 7 days post-transplant
Reported as:
Count of participants · Participants
Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant.
ParticipantsC1-Inhibitor (Berinert) (Human) (C1INH)Normal Saline
Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant.3028
PrimaryNumber of Dialysis Sessions Per Patient in the First 7 Days Post Transplant.

Mean quantity of dialysis sessions per patient in the first 7 days post transplant.

Time frame:
First 7 days post-transplant
Reported as:
Mean · dialysis sessions
Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant.
dialysis sessionsC1-Inhibitor (Berinert) (Human) (C1INH)Normal Saline
Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant.0.97 ± 1.221.54 ± 1.54
SecondarySerum Creatinine

Mean serum creatinine on day 90 in mg/dL

Time frame:
Up to 90 days post-transplant
Reported as:
Mean · mg/dL
Serum Creatinine
mg/dLC1-Inhibitor (Berinert) (Human) (C1INH)Normal Saline
Serum Creatinine1.3 ± 0.3171.7 ± 1.410
SecondaryCreatinine Clearance

Creatinine clearance calculated based on serum creatinine, milliliters per minute.

Time frame:
Up to 90 days post-transplant
Reported as:
Mean · ml/minute
Creatinine Clearance
ml/minuteC1-Inhibitor (Berinert) (Human) (C1INH)Normal Saline
Creatinine Clearance56.4 ± 15.55851.2 ± 17.335
Secondary24h Urine Output

24 hour urine output post-transplantation measured in milliliters

Time frame:
24 hours post-transplant
Reported as:
Mean · milliliters
24h Urine Output
millilitersC1-Inhibitor (Berinert) (Human) (C1INH)Normal Saline
24h Urine Output873.5 ± 1257.0607.8 ± 782.4
SecondaryMean Number of Patients on Dialysis

Mean number of patients on dialysis at 15 to 30 days post-transplant

Time frame:
15 to 30 days post-transplantation
Reported as:
Count of participants · Participants
Mean Number of Patients on Dialysis
ParticipantsC1-Inhibitor (Berinert) (Human) (C1INH)Normal Saline
Mean Number of Patients on Dialysis05
SecondaryNumber of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale)

DGF Scale: Grade 1 - immediate urine production and no need for dialysis with creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation \>70% Grade 2 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of \>70% with need for dialysis Grade 3 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation \<70% with no need for dialysis Grade 4 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of \<70% with need for dialysis.

Time frame:
First 7 days post-transplant
Reported as:
Count of participants · Participants
Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale)
ParticipantsC1-Inhibitor (Berinert) (Human) (C1INH)Normal Saline
Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale)1521
Other pre-specifiedOverall Incidence of Serious Adverse Events

Overall incidence of serious adverse events in the C1INH and placebo groups, number of events.

Time frame:
Up to 9 months post-transplant
Reported as:
Number · events
Overall Incidence of Serious Adverse Events
eventsC1-Inhibitor (Berinert) (Human) (C1INH)Normal Saline
Overall Incidence of Serious Adverse Events1116
Other pre-specifiedPatient Survival

Patient survival at 90 days post-transplantation

Time frame:
Up to 90 days post-transplant
Reported as:
Count of participants · Participants
Patient Survival
ParticipantsC1-Inhibitor (Berinert) (Human) (C1INH)Normal Saline
Patient Survival3535
Other pre-specifiedRate of Acute Cellular Rejection (ACR)

Number of acute cellular and antibody mediated rejection episodes by day 90.

Time frame:
Up to 90 days post-transplant
Reported as:
Number · episodes
Rate of Acute Cellular Rejection (ACR)
episodesC1-Inhibitor (Berinert) (Human) (C1INH)Normal Saline
Rate of Acute Cellular Rejection (ACR)00
Other pre-specifiedGraft Survival

Number of Participants with Graft Survival at 90 Days Post-Transplant

Time frame:
Day 90 Post-transplant
Reported as:
Count of participants · Participants
Graft Survival
ParticipantsC1-Inhibitor (Berinert) (Human) (C1INH)Normal Saline
Graft Survival3434

Adverse events

Collected over Adverse event data collected up to 9 months post transplant.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
C1-Inhibitor (Berinert) (Human) (C1INH)0/35 (0%)10/35 (28.6%)28/35 (80%)
Normal Saline0/35 (0%)10/35 (28.6%)26/35 (74.3%)
Most frequent serious events
Showing 10 of 24
Most frequent serious events
EventC1-Inhibitor (Berinert) (Human) (C1INH)Normal Saline
Abdominal painGastrointestinal disorders1/352/35
BacteremiaInfections and infestations1/350/35
Neutropenia/FeverInfections and infestations1/351/35
Viral infectionInfections and infestations1/350/35
Purulent Drainage from woundInfections and infestations1/350/35
Acute EncephalopathyInfections and infestations0/351/35
Sepsis from Urinary Tract InfectionInfections and infestations0/351/35
Diabetic KetoacidosisEndocrine disorders1/350/35
Flash pulmonary edemaRespiratory, thoracic and mediastinal disorders1/350/35
Dyspnea on exertionRespiratory, thoracic and mediastinal disorders1/350/35
Most frequent other events
Showing 10 of 14
Most frequent other events
EventC1-Inhibitor (Berinert) (Human) (C1INH)Normal Saline
HyperkalemiaMetabolism and nutrition disorders7/357/35
HypertensionCardiac disorders1/357/35
NauseaGastrointestinal disorders3/357/35
EdemaCardiac disorders7/354/35
FatigueGeneral disorders2/355/35
ConstipationGastrointestinal disorders3/353/35
VomitingGastrointestinal disorders2/353/35
Shortness of BreathCardiac disorders1/353/35
HyperglycemiaEndocrine disorders2/350/35
HypotensionCardiac disorders1/352/35

Baseline characteristics

Age, Continuous
Age, Continuous(years)C1-Inhibitor (Berinert) (Human) (C1INH)Normal SalineTotal
Mean57.66 ± 7.7458.14 ± 11.1857.9 ± 9.54
Sex: Female, Male
Sex: Female, Male(Participants)C1-Inhibitor (Berinert) (Human) (C1INH)Normal SalineTotal
Female151328
Male202242
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)C1-Inhibitor (Berinert) (Human) (C1INH)Normal SalineTotal
African-American448
Not African-American313162
Diabetes
Diabetes(Participants)C1-Inhibitor (Berinert) (Human) (C1INH)Normal SalineTotal
Count of participants212041
Donor Age
Donor Age(years)C1-Inhibitor (Berinert) (Human) (C1INH)Normal SalineTotal
Mean49.17 ± 12.3545.57 ± 15.6947.37 ± 14.13
Donor Creatinine
Donor Creatinine(mg/dL)C1-Inhibitor (Berinert) (Human) (C1INH)Normal SalineTotal
Mean1.78 ± 1.441.75 ± 1.921.77 ± 1.69
Donor DCD Cause of Death
Donor DCD Cause of Death(Participants)C1-Inhibitor (Berinert) (Human) (C1INH)Normal SalineTotal
Count of participants111223
Donor KDPI
Donor KDPI(%)C1-Inhibitor (Berinert) (Human) (C1INH)Normal SalineTotal
Mean67.71 ± 21.8364.63 ± 25.3966.17 ± 23.56

7 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
09

References and documents

Publications

  • Dalle Lucca JJ, Li Y, Simovic M, Pusateri AE, Falabella M, Dubick MA, Tsokos GC. Effects of C1 inhibitor on tissue damage in a porcine model of controlled hemorrhage. Shock. 2012 Jul;38(1):82-91. doi: 10.1097/SHK.0b013e31825a3522. PubMed 22683724 ↗
  • Pascual J, Zamora J, Pirsch JD. A systematic review of kidney transplantation from expanded criteria donors. Am J Kidney Dis. 2008 Sep;52(3):553-86. doi: 10.1053/j.ajkd.2008.06.005. PubMed 18725015 ↗
  • Castellano G, Melchiorre R, Loverre A, Ditonno P, Montinaro V, Rossini M, Divella C, Battaglia M, Lucarelli G, Annunziata G, Palazzo S, Selvaggi FP, Staffieri F, Crovace A, Daha MR, Mannesse M, van Wetering S, Paolo Schena F, Grandaliano G. Therapeutic targeting of classical and lectin pathways of complement protects from ischemia-reperfusion-induced renal damage. Am J Pathol. 2010 Apr;176(4):1648-59. doi: 10.2353/ajpath.2010.090276. Epub 2010 Feb 11. PubMed 20150432 ↗
  • Giral-Classe M, Hourmant M, Cantarovich D, Dantal J, Blancho G, Daguin P, Ancelet D, Soulillou JP. Delayed graft function of more than six days strongly decreases long-term survival of transplanted kidneys. Kidney Int. 1998 Sep;54(3):972-8. doi: 10.1046/j.1523-1755.1998.00071.x. PubMed 9734625 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2014, a primary completion of Mar 2017 and a completion of Mar 2017. It does not say whether these dates are actual or estimated.

Results were first posted in Jun 2018, 1 year 3 months after primary completion.

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

Registered
Feb 19, 2014
First posted
May 9, 2014
Start
Sep 2014
Primary completionActual
Mar 13, 2017
CompletionActual
Mar 13, 2017
Results first posted
Jun 25, 2018
Last update
Jun 25, 2018
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 Jun 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02134314
Lead sponsor
Cedars-Sinai Medical Center
Responsible party
Stanley Jordan, MD (Medical Director, Kidney Transplant Program; Director of Transplant Immunology and Nephrology, Cedars-Sinai Medical Center) — Principal investigator
First posted
May 9, 2014
Start date
Sep 2014
Primary completion
Mar 13, 2017
Completion
Mar 13, 2017
Results posted
Jun 25, 2018
Last update
Jun 25, 2018

Study contacts

Stanley C Jordan, MD
principal investigator · Cedars-Sinai Medical Center, Los Angeles, CA
Ashley Vo, PharmD
study director · Cedars-Sinai Medical Center, Los Angeles, CA

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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