PA21 Safety and Efficacy in Adult Chinese Subjects

NCT03644264 | Completed Phase 3

• 1 other identifier: PA-CL-CHINA-01
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the efficacy of PA21 in comparison with sevelamer carbonate (Renvela®) in lowering and maintaining serum phosphorus in adult Chinese subjects with CKD on dialysis after 12 weeks of treatment.

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis; Hyperphosphatemia

Keywords

Chronic Kidney Disease; Hyperphosphatemia; Dialysis

Outcome Measures

Primary Outcomes (1)

• Serum phosphorus (mmol/l )

  Change from baseline in serum phosphorus levels at Week 12: comparison between PA21 group and sevelamer carbonate group.

  baseline and 12 weeks

Secondary Outcomes (12)

• Serum phosphorus (mmol/l )

  baseline, weeks 1, 2, 4, 6, 8, 12

• Serum phosphorus (mmol/l)

  baseline, weeks 1, 2, 4, 6, 8, 12

• Adverse events (AEs)

  baseline, weeks 1, 2, 4, 6, 8, 12

• Diarrhoea.

  baseline, weeks 1, 2, 4, 6, 8, 12

• Withdrawals due to AEs

  baseline, weeks 1, 2, 4, 6, 8, 12

Study Arms (2)

PA21 tablets containing 500 mg of iron

EXPERIMENTAL

PA21 chewable tablets standardised to contain 500 mg of iron. PA21 500 mg (iron) chewable tablet contains approximately 2.5 g PA21 drug substance (sucroferric oxyhydroxide). Starting dose will be 1,500 mg/day (3 tablets/day (1 tablet per meal)). Dose increases or decreases of 500 mg/day (1 tablet/day) are permitted. The maximum dose of PA21 will be 3,000 mg/day (6 x 500 mg tablets/day) and the minimum dose will be 1,000 mg/day (2 x 500 mg tablets/day).

Drug: PA21

Sevelamer carbonate: Renvela® tablets

ACTIVE COMPARATOR

Starting dose will be 2.4 g/day (3 tablets/day). Dose increases or decreases of 2.4 g/day (3 tablets/day (1 tablet per meal)) The maximum dose of sevelamer carbonate will be 14.4 g/day (18 tablets/day) and the minimum dose will be 2.4 g/day (3 tablets/day).

Drug: sevelamer carbonate

Interventions

PA21 DRUG

sucroferric oxyhydroxide is a mixture of polynuclear iron(III)-oxyhydroxide (about 33% m/m), sucrose (about 30% m/m), and starches (about 28% m/m) and contains ≤10% m/m water.

Also known as: sucroferric oxyhydroxide, Velphoro®

PA21 tablets containing 500 mg of iron

sevelamer carbonate DRUG

sevelamer carbonate tablets containing 800 mg of sevelamer carbonate.

Also known as: Renvela®

Sevelamer carbonate: Renvela® tablets

Eligibility Criteria

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

You may qualify if:

• Chinese subjects receiving either maintenance haemodialysis (HD) or peritoneal dialysis (PD) for at least 12 weeks prior to screening. No home HD or nocturnal HD (overnight stay at site) will be allowed
• Subjects with a history of hyperphosphataemia (HP).
• Subjects with serum phosphorus levels \>5.5 mg/dl (\>1.78 mmol/l) at screening or during the washout period.
• Male and female adult subjects (aged ≥18 years at time of consent).
• Subjects with the ability to understand the requirements of the study and abide by the study restrictions, and who agree to return for the required assessments (in the Investigator's opinion).
• Subject (or legally acceptable representative) has provided the appropriate written informed consent. Subject must provide written informed consent before any study-specific procedures are performed including screening procedures.

You may not qualify if:

• Subjects with intact parathyroid hormone (iPTH) levels \>800 ng/l (\>800 pg/ml or 88 pmol/l) at screening. Subjects with iPTH \>600 ng/l (\>600 pg/ml or 66 pmol/l) at screening must be considered stable (in the Investigator's opinion).
• Subjects with planned or expected parathyroidectomy within the next 6 months (in the Investigator's opinion).
• Subjects on peritoneal dialysis (PD) with a history of peritonitis in the last 3 months or ≥3 episodes in the last 12 months.
• Subjects with serum total calcium \>10.5 mg/dl (\>2.6 mmol/l) or \<7.6 mg/dl (1.9 mmol/l) at screening.
• Subjects with:
• Any history of major gastrointestinal (GI) surgery likely to influence the outcome of treatment with PBs
• Clinically significant, active GI disorders (e.g., active peptic ulcer, Crohn's disease, colitis ulcerative, irritable bowel syndrome, intestinal motility disorder (symptomatic gastroparesis (during treatment or untreated), intestinal obstruction, moderate/severe constipation (including persistent symptoms with regular use of laxatives or enemas and limitations in activities of daily living), intestinal pseudo-obstruction, megacolon, mechanical obstruction)) or any GI disorders under medical treatment.
• Clinically significant, active hepatic disorders or any hepatic disorder under medical treatment
• Subjects currently with (in the Investigator's opinion):
• Swallowing difficulties/dysphagia
• Estimated life expectancy of less than 12 months
• Anticipated renal transplantation during study participation
• Subjects with known seropositivity to human immunodeficiency virus or positive HIV test at screening.
• Subjects with active/current fulminant hepatitis B infections and/or hepatitis C virus ribonucleic acid positivity at screening.
• Subjects with a history of haemochromatosis or other iron accumulation disorders that might lead to iron overload.

Sponsors & Collaborators

• Vifor Fresenius Medical Care Renal Pharma: lead

Study Sites (1)

Southern Medical University Nanfang Hospital

Guangzhou, Guangdong, China

Location

Related Publications (2)

• Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

  PMID: 40576086 DERIVED

• Liu J, Zuo L, Walpen S, Bernard L, Marty M, Enoiu M. Efficacy and Safety of Sucroferric Oxyhydroxide Compared with Sevelamer Carbonate in Chinese Dialysis Patients with Hyperphosphataemia: A Randomised, Open-Label, Multicentre, 12-Week Phase III Study. Nephron. 2024;148(1):22-33. doi: 10.1159/000531869. Epub 2023 Jul 20.

  PMID: 37473746 DERIVED

MeSH Terms

Conditions

Hyperphosphatemia; Renal Insufficiency, Chronic

Interventions

sucroferric oxyhydroxide; Sevelamer

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; 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 Officials

• Hou Fanfan, MD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Open-label, Randomised, Active-controlled, Parallel Group, Multicentre,

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 23, 2018
• Study Start: August 31, 2018
• Primary Completion: August 21, 2020
• Study Completion: August 21, 2020
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)