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Trial record 29 of 380 for:    FERRIC CATION

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03984760
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : August 28, 2019
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)
Estimated 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
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : October 20, 2020

Resource links provided by the National Library of Medicine


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.



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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


Contacts
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Contact: Shandong Weigao Panion Pharmaceutical Co. Ltd. +86 13863036612 lina-xia@weigaogroup.com

Locations
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China
The General Hospital of the People's Liberation Army (PLAGH) Not yet recruiting
Beijing, China
Contact: Xiangmei Chen         
Principal Investigator: Xiangmei Chen         
The Second Hospital of Jilin University Not yet recruiting
Changchun, China
Contact: Ping Luo         
Principal Investigator: Ping Luo         
Daping Hospital Not yet recruiting
Chongqing, China
Contact: Yani He         
Principal Investigator: Yani He         
The First Affiliated Hospital of Dalian Medical University Not yet recruiting
Dalian, China
Contact: Hongli Lin         
Principal Investigator: Hongli Lin         
The Fifth Affiliated Hospital of Guangzhou Medical University Not yet recruiting
Guangzhou, China
Contact: Yuehong Yan         
Principal Investigator: Yuehong Yan         
The First Affiliated Hospital/School Of Clinical Medicine of Guangdong Pharmaceutical University Recruiting
Guangzhou, China
Contact: Lu Lv         
Principal Investigator: Lu Lv         
Meihekou Central Hospital Not yet recruiting
Meihekou, China
Contact: Yan Guan         
Principal Investigator: Yan Guan         
Jiangxi Provincial People's Hospital Not yet recruiting
Nanchang, China
Contact: Aimin Zhong         
Principal Investigator: Aimin Zhong         
The Affiliated Hospital of Qingdao University Not yet recruiting
Qingdao, China
Contact: Yan Xun         
Principal Investigator: Yan Xun         
Changhai Hospital Not yet recruiting
Shanghai, China
Contact: Zhiyong Guo         
Principal Investigator: Zhiyong Guo         
Shengjing Hospital of China Medical University Not yet recruiting
Shenyang, China
Contact: Detian Li         
Principal Investigator: Detian Li         
Tonghua Central Hospital Not yet recruiting
Tonghua, China
Contact: Shuping Zhao         
Principal Investigator: Shuping Zhao         
Renmin Hospital of Wuhan University Not yet recruiting
Wuhan, China
Contact: Guohua Ding         
Principal Investigator: Guohua Ding         
Zhongnan Hospital of Wuhan University Not yet recruiting
Wuhan, China
Contact: Hua Shui         
Principal Investigator: Hua Shui         
Henan Provincial People's Hospital Not yet recruiting
Zhengzhou, China
Contact: Fengmin Shao         
Principal Investigator: Fengmin Shao         
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     History of Changes
Other Study ID Numbers: WG-PBB00302
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
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
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Phosphorus Metabolism Disorder
Additional relevant MeSH terms:
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Ferric Compounds
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases
Citric Acid
Sodium Citrate
Sevelamer
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Hematinics