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

NCT04456803 | Completed Phase 3

• 2 other identifiers: CTS-CO-1642CTR20190978
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 20

Brief Summary

To evaluate the efficacy and safety of ferric citrate tablet in the control of serum phosphorus levels in patients with chronic kidney disease undergoing hemodialysis.

Conditions

Hyperphosphatemia; End Stage Renal Disease; ESRD

Outcome Measures

Primary Outcomes (1)

• The change in serum phosphorus levels

  The change in serum phosphorus levels at the end of treatment as compared to baseline (before the first dose).

  12 Weeks

Secondary Outcomes (5)

• Changes in serum phosphorus levels

  week 2, 4, 6, 8

• Area under the curve of serum phosphorus level

  week 0, 2, 4, 6, 8, 12

• The proportion of subjects whose serum phosphorus levels reached the target

  week 4, 6, 8 and 12

• The change in serum calcium (corrected) levels.

  week 4, 8 and 12

• The change in the level of intact-PTH levels.

  week 4, 8 and 12

Study Arms (2)

Ferric citrate tablet

EXPERIMENTAL

Ferric citrate arm will receive ferric citrate tablets three times a day with each meal.

Drug: Ferric citrate tablet

Sevelamer carbonate tablet

ACTIVE COMPARATOR

Sevelamer carbonate arm will receive sevelamer carbonate tablets three times a day with each meal.

Drug: Sevelamer carbonate tablet

Interventions

Ferric citrate tablet DRUG

250mg/tablet, manufactured by Sinomune Pharmaceutical

Ferric citrate tablet

Sevelamer carbonate tablet DRUG

800 mg/tablet, manufactured by Genzyme Ireland Limited

Also known as: Renvela

Sevelamer carbonate tablet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the age of 18 and 75 years (including the boundary value) and no gender limitation;
• Patients who maintain the hemodialysis schedule (including hemofiltration (HF) hemodialysis (HDF) hemoperfusion (HP)) as not less than 3 times a week in the 3 months before random enrollment.
• Patients with a serum phosphorus level between 1.97 to 3.23 mmol/L (excluding the boundary value) after washout.
• Kt/Vurea ≥1.2 or URR ≥65%.
• Before the screening period, CKD-MBD related drug treatment is stable for more than one month, including the use of vitamin D (active vitamin D, vitamin D analogues, etc.) or calcimimetics (cinacalcet, etc.) and the dose remains unchanged.
• The expected survival is greater than 6 months.
• Willing to give written informed consent.

You may not qualify if:

• Patients with a serum ferritin level ≥800 ng/mL or TSAT ≥50%.
• Patients with hemochromatosis or patients receiving treatment for iron overload, or patients with paroxysmal sleep hemoglobinuria.
• Patients who received blood transfusions within 3 months prior to Screening, or patients with hemoglobin ≤60 g/L.
• Patients with intact-PTH \>1000 pg/mL
• Patients complicated with any of the following gastrointestinal diseases: acute peptic ulcer, chronic ulcerative colitis, localized enteritis, intestinal obstruction, habitual constipation (number of stools once per week), and chronic diarrhea (number of stools four times per day), or patients with a history of gastrectomy or enterectomy or patients who had undergone gastrointestinal surgery within 3 months prior to Screening, or patients with dysphagia.
• 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.
• Patients with a history of parathyroidectomy (PTx) or percutaneous anhydrous ethanol injection (PEIT) within 6 months.
• Patients with uncontrolled diabetes or uncontrolled high blood pressure or current active infectious diseases such as active viral hepatitis.
• Patients with a history of severe allergies may be allergic to research drugs.
• Patients with cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.) or cardiovascular disease (congestive heart failure of Class III or severer in NYHA classification) requiring hospitalization within 6 months prior to Screening, or patients who use antiarrhythmic drugs to control arrhythmias or who use antiepileptic drugs to control seizures.
• Patients who plan to receive a kidney transplant during the study period.
• Patients with a history of drug and alcohol abuse
• Patients with active or advanced malignancy.
• Women who are pregnant or lactating
• Patients complicated with active bleeding or requiring anticoagulation therapy with citrate in hemodialysis

Sponsors & Collaborators

• Sinomune Pharmaceutical Co., Ltd: lead

Study Sites (20)

The first affiliated hospital of Baotou medical college

Baotou, China

Location

Beijing Tongren Hospital

Beijing, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

The Second Xiangya Hospital of Central South University

Changsha, China

Location

Xiangya Hospital Central South University

Changsha, China

Location

The second hospital of Dalian medical university

Dalian, China

Location

The affiliated hospital of Inner Mongolia Medical University

Hohhot, China

Location

The second people's hospital of Huaian

Huai'an, China

Location

Jinan central hospital

Jinan, China

Location

Shandong province Qianfoshan hospital

Jinan, China

Location

Zhongnan Hospital Southeast University

Nanjing, China

Location

The people's hospital of Guangxi Zhuang Autonomous Region

Nanning, China

Location

Shenzhen people's hospital

Shenzhen, China

Location

The third hospital of Hebei medical university

Shijiazhuang, China

Location

General Hospital of Tianjin Medical University

Tianjin, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, China

Location

First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

Henan provincal people's hospital

Zhengzhou, China

Location

Zhengzhou People's Hospital

Zhengzhou, China

Location

Zhuzhou Central Hospital

Zhuzhou, China

Location

MeSH Terms

Conditions

Hyperphosphatemia; Kidney Failure, Chronic

Interventions

ferric citrate; Sevelamer

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: May 24, 2019
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

CN (20)