Clinical trial NCT03984760: Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperphosphatemia
End Stage Renal Disease
ESRD
Keywords: Kidney Diseases
Kidney Failure, Chronic
Hyperphosphatemia
Renal Insufficiency, Chronic
Renal Insufficiency
Phosphorus Metabolism Disorder
Lead sponsor: Panion & BF Biotech Inc.
Sponsor class: INDUSTRY
Collaborators: name: Shandong Weigao Panion Pharmaceutical Co. Ltd.
First posted: 2019-06-13
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: The change in serum phosphorus levels
timeFrame: 12 Weeks
Secondary outcomes:
measure: Serum phosphorus levels
timeFrame: 12 Weeks
measure: The proportion of subjects whose serum phosphorus levels reached the target range.
timeFrame: 12 Weeks
measure: The response rate of serum phosphorus
timeFrame: 12 Weeks
measure: The change in serum calcium (corrected) levels
timeFrame: 12 Weeks
measure: The change in the [Ca] × [P] product relative
timeFrame: 12 Weeks
measure: The change in the level of intact-PTH levels
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Baotou
country: China
facility: Baotou Central Hospital
city: Beijing
country: China
facility: The General Hospital of the People's Liberation Army (PLAGH)
city: Changchun
country: China
facility: The Second Hospital of Jilin University
city: Chongqing
country: China
facility: Daping Hospital
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital of Guangzhou Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital/School Of Clinical Medicine of Guangdong Pharmaceutical University
city: Jilin
country: China
facility: Jilin Guowen Hospital
city: Jiujiang
country: China
facility: Jiujiang University Affiliated Hospital
city: Meihekou
country: China
facility: Meihekou Central Hospital
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: BenQ Medical Center
city: Nanjing
country: China
facility: JiangSu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Shanghai
country: China
facility: Changhai Hospital
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
city: Tonghua
country: China
facility: Tonghua Central Hospital
city: Wuhan
country: China
facility: Fifth Hospital in Wuhan
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
Study officials:
affiliation: The General Hospital of the People's Liberation Army (PLAGH)
name: Xiangmei Chen
role: PRINCIPAL_INVESTIGATOR
References: