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Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03984760
Recruitment Status : Completed
First Posted : June 13, 2019
Last Update Posted : March 10, 2021
Sponsor:
Collaborator:
Shandong Weigao Panion Pharmaceutical Co. Ltd.
Information provided by (Responsible Party):
Panion & BF Biotech Inc.

Brief Summary:
To evaluate the efficacy and safety of ferric citrate capsules for the treatment of hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis

Condition or disease Intervention/treatment Phase
Hyperphosphatemia End Stage Renal Disease ESRD Drug: Ferric Citrate Drug: Sevelamer Carbonate Phase 3

Detailed Description:
This is a multicenter, randomized, open-label, active-controlled, parallel, phase III study which aims to assess the efficacy and safety of ferric citrate capsules for the treatment of hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis. This study is consisting of a Screening/Washout period (14 days) and a Treatment/Observation period (12 weeks). During the Treatment period, the subjects will be randomly assigned to the ferric citrate capsule group (study group) or sevelamer carbonate tablet group (control group) in the ratio of 1:1.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-Label, Active-Controlled, Parallel Study to Assess the Efficacy and Safety of Ferric Citrate Capsules for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis
Actual Study Start Date : June 19, 2019
Actual Primary Completion Date : February 20, 2021
Actual Study Completion Date : February 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Ferric Citrate Capsule
Ferric Citrate Capsule, product specification: 500 mg/cap, manufactured by Panion & BF Biotech Inc.
Drug: Ferric Citrate
Take the capsules with meals or immediately after meals.

Active Comparator: Sevelamer Carbonate Tablet
Sevelamer carbonate tablet group, product specification: 800 mg/tablet, manufactured by Genzyme Ireland Limited
Drug: Sevelamer Carbonate
Take the tablets with meals.




Primary Outcome Measures :
  1. The change in serum phosphorus levels [ Time Frame: 12 Weeks ]
    The change in serum phosphorus levels at the end of treatment (Visit 10 or ET) as compared to baseline (before the first dose).


Secondary Outcome Measures :
  1. Serum phosphorus levels [ Time Frame: 12 Weeks ]
    Serum phosphorus levels at the end of treatment;

  2. The proportion of subjects whose serum phosphorus levels reached the target range. [ Time Frame: 12 Weeks ]
    The proportion of subjects whose serum phosphorus levels reached the target range (3.5 to 5.5 mg/dL, 1.13 to 1.78 mmol/L) at the end of the treatment;

  3. The response rate of serum phosphorus [ Time Frame: 12 Weeks ]
    The response rate of serum phosphorus at the end of treatment (defined as reduction of the serum phosphorus level exceeds 25% as compared to baseline);

  4. The change in serum calcium (corrected) levels [ Time Frame: 12 Weeks ]
    The change in serum calcium (corrected) levels at the end of treatment as compared to baseline;

  5. The change in the [Ca] × [P] product relative [ Time Frame: 12 Weeks ]
    The change in the [Ca] × [P] product relative at the end of treatment as compared to baseline;

  6. The change in the level of intact-PTH levels [ Time Frame: 12 Weeks ]
    The change in the level of intact-PTH levels at the end of treatment as compared to baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing to give written informed consent.;
  2. Between the age of 18 and 75 years (including the boundary value);
  3. Patients who maintain the hemodialysis schedule as 3 times a week and the dialysis schedule should remain unchanged during the study period;
  4. At Screening, patients who have received phosphate binder for at least 4 weeks and have a serum phosphorus level between 2.5 and 8.0 mg/dL (0.81 to 2.58 mmol/L) (excluding the boundary value) after treatment;
  5. Patients with a serum phosphorus level between 5.5 and 10.0 mg/dL (1.78 to 3.23 mmol/L) (excluding the boundary value) after washout.

Exclusion Criteria:

  1. Patients with severe gastrointestinal diseases (such as acute peptic ulcer, chronic ulcerative colitis, regional enteritis, ileus) or patients with dysphagia;
  2. Patients with a history of gastrectomy or enterectomy (excluding endoscopic excision or caecectomy) or patients who had undergone gastrointestinal surgery within 3 months prior to Screening;
  3. Patients with severe constipation (times of bowel movement≤ 1 time/week), chronic diarrhea (times of bowel movement≥ 4 times/day), severe gastrointestinal motility disorder;
  4. Patients with hemochromatosis or patients receiving treatment for iron overload, or patients with a serum ferritin level >800 ng/mL or TSAT >50% at Screening;
  5. Patients with a serum calcium level (corrected) <8.0 mg/dL (2.0 mmol/L) or >11.0 mg/dL (2.75 mmol/L) after washout;
  6. Patients with intact-PTH>800pg/mL at Screening, or patients undergone parathyroid surgery within 6 months prior to Screening or requiring parathyroid surgery;
  7. Patients who received blood transfusions for treating anemia within 3 months prior to Screening;
  8. Patients who require phosphorus-binding agents containing aluminum, magnesium, calcium and lanthanum in addition to the study drug or patients who require an antacid with a phosphorus binding effect during the study period;
  9. Patients who require citrate preparation as an anticoagulant during hemodialysis treatment during the study period;
  10. Patients with impaired liver function (hepatic dysfunction or serum total bilirubin, aspartate aminotransferase or alanine aminotransferase ≥ 2 times the upper limit of normal) or patients with cirrhosis;
  11. Patients with cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.) or cardiovascular disease (congestive heart failure of Class III or severer in NYHA classification, acute myocardial infarction, unstable angina, etc.) requiring hospitalization within 6 months prior to Screening;
  12. Patients who are known to be intolerant to sevelamer carbonate tablet;
  13. Patients with a history of allergies to iron preparations or those who are intolerant to iron preparations;
  14. Patients who are scheduled to have a kidney transplant during the study period;
  15. Patients with a current or past history of malignancy within 5 years prior to Screening;
  16. Women who are pregnant or lactating, or patients who are unable to take effective contraception from screening to 6 months after discontinuation (including male subjects and their female spouses);
  17. Patients who had participated in other clinical studies and other received investigational drug product within 1 month or 5 half-lives of the drug product (whichever is longer) prior to Screening;
  18. Patients who are not suitable for participating in the trial according to the investigator's judgment;
  19. Patients who are unwilling or unable to follow the protocol process.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984760


Locations
Show Show 24 study locations
Sponsors and Collaborators
Panion & BF Biotech Inc.
Shandong Weigao Panion Pharmaceutical Co. Ltd.
Investigators
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Principal Investigator: Xiangmei Chen The General Hospital of the People's Liberation Army (PLAGH)
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Responsible Party: Panion & BF Biotech Inc.
ClinicalTrials.gov Identifier: NCT03984760    
Other Study ID Numbers: WG-PBB00302
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Panion & BF Biotech Inc.:
Kidney Diseases
Kidney Failure, Chronic
Hyperphosphatemia
Renal Insufficiency, Chronic
Renal Insufficiency
Phosphorus Metabolism Disorder
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases
Sevelamer
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action