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CompletedNCT03079869Updated Jan 13, 2022Results posted

Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients

A Phase 4 interventional study of Ferric Citrate in Hyperphosphatemia, sponsored by Kaiser Permanente. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-01-13.

Sponsored by Kaiser Permanente · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Sex
All
01

Study summary

Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California

Read the detailed description

PROTOCOL SUMMARY

Title: Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California

Short Title: FeCitrate

Protocol Number: KP FeCitrate

Study Phase: 4

Study Site(s): Los Angeles Kaiser Sunset Medical Center

Number of Subjects: 55

Study Arms: 1

Indication: Hyperphosphatemia in end stage renal disease

Primary Purpose: To evaluate the efficacy of ferric citrate for control of serum phosphorus levels and maintenance of adequate iron stores among dialysis-dependent patients before and after conversion from traditional phosphate binders in a "real world" environment

Overview of Study Design: Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).

Investigational Product Administration: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.

Study Endpoint: Mean serum phosphorus levels and rate of successful phosphorus control (\<5.5mg/dl) 6 months before and after treatment with ferric citrate

Statistical Methods: Not powered to detect statistical significance

02

Conditions studied

  • Hyperphosphatemia

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Currently using 3 to 18 pills per day of calcium acetate, sevelamer, lanthanum, or calcium carbonate
  • Mean serum phosphorus 4.0-\<8.0 mg/dl for 6 months prior to enrollment
  • No allergy to iron
  • Mean corrected serum calcium > 8.0 mg/dl for 6 months prior to enrollment
  • Mean PTH \< 1000 pg/ml for 6 months prior to enrollment
  • Mean ferritin \< 1500 ng/ml and mean iron sat \< 50% for 6 months prior to enrollment

Exclusion criteria

Exclusion Criteria:

  • History of gastrointestinal bleeding within past 6 months
  • History of hospitalization for gastroparesis, bowel obstruction, or abdominal surgery within past 6 months
  • Acute kidney injury equal to or less than 3 months before the initial screening date
  • Active malignancy
  • Functioning renal transplant
  • Patients with iron overload syndrome (e.g., Hemochromatosis)
  • History autoimmune disease, hemoglobinopathy, hemochromatosis, sickle cell disease
  • Active or past history of calciphylaxis
04

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Other
    Ferric Citrate

    Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.

    Drug: Ferric Citrate

Interventions

  • DrugFerric Citrate

    One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.

    Also known as: Auryxia

05

What researchers measure

Primary outcomes

  1. Phosphorus Levels

    Serum phosphorus levels measured by mg/dL from the 6 months prior to enrollment were compared to serum phosphorus levels collected during the 6 months of ferric citrate use

    Time frame: 6 months

Secondary outcomes

  1. Intravenous (IV) Iron

    The amount of intravenous (IV) iron in mg used per month by participants for 6 months before and 6 months on Ferric Citrate treatment.

    Time frame: 6 months

  2. Erythropoiesis Stimulating Agents (ESA) Dose

    Mean Erythropoiesis Stimulating Agents (ESA) use from the 6 months prior to enrollment were compared to ESA use during the 6 months of ferric citrate use. The mean ESA dose units given to each participant per month was used in the analysis of this outcome.

    Time frame: 6 months

  3. Median Pill Count

    median pill count of ferric citrate pills/day required to maintain phosphorus control

    Time frame: 6 months

06

Results

Posted Jan 13, 2022

Participant flow

Study subjects who received either hemodialysis (HD) or peritoneal dialysis (PD) at Kaiser Permanente Southern California, Los Angeles Medical Center were eligible for recruitment.

Participant flow — Overall Study
MilestoneFerric Citrate - HemodialysisFerric Citrate - Peritoneal Dialysis
Started2827
Completed1516
Not completed1311
Withdrew: Adverse event68
Withdrew: Withdrawal by subject41
Withdrew: Protocol withdrawal criteria-off drug > 2 weeks32

Outcome measures

PrimaryPhosphorus Levels

Serum phosphorus levels measured by mg/dL from the 6 months prior to enrollment were compared to serum phosphorus levels collected during the 6 months of ferric citrate use

Time frame:
6 months
Reported as:
Mean · mg/dL
Phosphorus Levels
mg/dLFerric Citrate - HemodialysisFerric Citrate - Peritoneal Dialysis
Pre-treatment5.3 ± 15.6 ± 0.8
On-treatment5.4 ± 1.16 ± 1.8
SecondaryIntravenous (IV) Iron

The amount of intravenous (IV) iron in mg used per month by participants for 6 months before and 6 months on Ferric Citrate treatment.

Time frame:
6 months
Reported as:
Mean · mg/mo
Intravenous (IV) Iron
mg/moFerric Citrate - HemodialysisFerric Citrate - Peritoneal Dialysis
Pre-Treatment249.2 ± 215.621.2 ± 43.1
On-Treatment102 ± 137.511.6 ± 33.7
SecondaryErythropoiesis Stimulating Agents (ESA) Dose

Mean Erythropoiesis Stimulating Agents (ESA) use from the 6 months prior to enrollment were compared to ESA use during the 6 months of ferric citrate use. The mean ESA dose units given to each participant per month was used in the analysis of this outcome.

Time frame:
6 months
Reported as:
Mean · units/mo
Erythropoiesis Stimulating Agents (ESA) Dose
units/moFerric Citrate - HemodialysisFerric Citrate - Peritoneal Dialysis
Pre-Treatment28761.1 ± 41314.116724.4 ± 14042.3
Post-Treatment16525.8 ± 1691716780.1 ± 13433.7
SecondaryMedian Pill Count

median pill count of ferric citrate pills/day required to maintain phosphorus control

Time frame:
6 months
Reported as:
Median · tablets per day
Median Pill Count
tablets per dayFerric Citrate - HemodialysisFerric Citrate - Peritoneal Dialysis
Phosphate binder pill count prior to Ferric Citrate use9.5 (6.8 to 13.8)6 (6.0 to 9.0)
Phosphate binder pill count during Ferric Citrate use6.0 (4.5 to 9.0)4.5 (2.0 to 6.0)

Adverse events

Collected over 7 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ferric Citrate - Hemodialysis0/27 (0%)7/27 (25.9%)23/27 (85.2%)
Ferric Citrate - Peritoneal Dialysis0/27 (0%)10/27 (37%)27/27 (100%)
Most frequent serious events
Showing 10 of 21
Most frequent serious events
EventFerric Citrate - HemodialysisFerric Citrate - Peritoneal Dialysis
Arteriovenous fistulaBlood and lymphatic system disorders2/270/27
Congestive heart failure exacerbationCardiac disorders0/271/27
gallstone pancreatitisGastrointestinal disorders0/271/27
Gastrointestinal HemorrhageGastrointestinal disorders1/270/27
HematocheziaGastrointestinal disorders1/270/27
Abdominal swellingGeneral disorders0/271/27
PeritonitisGeneral disorders0/271/27
Right foot infectionInfections and infestations0/271/27
Chest painMusculoskeletal and connective tissue disorders0/271/27
Chronic back painMusculoskeletal and connective tissue disorders1/270/27
Most frequent other events
Showing 10 of 14
Most frequent other events
EventFerric Citrate - HemodialysisFerric Citrate - Peritoneal Dialysis
Black stoolGastrointestinal disorders20/2725/27
DiarrheaGastrointestinal disorders10/2710/27
ConstipationGastrointestinal disorders4/275/27
Nausea, vomitingGastrointestinal disorders1/274/27
Itching/rashSkin and subcutaneous tissue disorders2/274/27
Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders2/274/27
Decreased appetiteMetabolism and nutrition disorders0/273/27
Bloating/GasGastrointestinal disorders2/272/27
Abdominal painGastrointestinal disorders1/272/27
FatigueGeneral disorders2/270/27

Baseline characteristics

A total of 28 Hemodialysis (HD) patients were enrolled. Of these, 2 patients withdrew prior to receiving the study drug, 3 patients withdrew within the first 2 weeks due to adverse event, 2 patients withdrew themselves after 1 day. Only 1 of the 27 Peritoneal Dialysis (PD) patients enrolled in the study withdrew.

Age, Continuous
Age, Continuous(years)Ferric Citrate - HemodialysisFerric Citrate - Peritoneal DialysisTotal
Mean65 ± 1357 ± 1460 ± 14
Sex: Female, Male
Sex: Female, Male(Participants)Ferric Citrate - HemodialysisFerric Citrate - Peritoneal DialysisTotal
Female6713
Male151934
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Ferric Citrate - HemodialysisFerric Citrate - Peritoneal DialysisTotal
Asian7613
African American639
White71421
Unknown Race134
Hispanic71219
Not Hispanic141327
Unknown Ethnicity011
Region of Enrollment
Region of Enrollment(participants)Ferric Citrate - HemodialysisFerric Citrate - Peritoneal DialysisTotal
United States212647
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)Ferric Citrate - HemodialysisFerric Citrate - Peritoneal DialysisTotal
Mean28.4 ± 4.727.8 ± 5.228.1 ± 4.9
Smoking
Smoking(Participants)Ferric Citrate - HemodialysisFerric Citrate - Peritoneal DialysisTotal
Count of participants10616
Duration on Dialysis
Duration on Dialysis(months)Ferric Citrate - HemodialysisFerric Citrate - Peritoneal DialysisTotal
Mean29 ± 32.141.4 ± 49.236.2 ± 42.5
Diabetes
Diabetes(Participants)Ferric Citrate - HemodialysisFerric Citrate - Peritoneal DialysisTotal
Count of participants8715

4 further baseline measures are reported on the registry.

07

Study locations

1 site
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California 90027, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 5, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03079869
Lead sponsor
Kaiser Permanente
Collaborators
Keryx Biopharmaceuticals
Responsible party
Sponsor
First posted
Mar 15, 2017
Start date
May 1, 2017
Primary completion
Sep 14, 2019
Completion
Sep 14, 2019
Results posted
Jan 13, 2022
Last update
Jan 13, 2022

Study contacts

Victoria Kumar, MD
principal investigator · Kaiser Permanente

Oversight

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

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