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Chronic Kidney Disease Requiring Chronic DialysisPhase 3NCT03644264

PA21 Safety and Efficacy in Adult Chinese Subjects

A Phase 3 study testing PA21 and sevelamer carbonate in people with Chronic Kidney Disease Requiring Chronic Dialysis and Hyperphosphatemia, run by Vifor Fresenius Medical Care Renal Pharma at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PA21 and sevelamer carbonate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
286 participants
Where
1 siteChina
Study dates
31 Aug 2018to 21 Aug 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
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  • 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.
  • Subjects with serum ferritin >800 mcg/l (1,797.6 pmol/l) or transferrin saturation (TSAT) >50% at screening.
  • Subjects with raised alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of the normal range at screening.
  • Subject is taking any prohibited medication(s) which cannot be stopped at least one week before study treatment start. Prohibited medications include: oral calcium supplements, any drugs/agents having a phosphate binding action that contain aluminium, magnesium or calcium (apart from hyperkalaemia drugs), phosphate binders in addition to sevelamer carbonate), nicotinamide, oral iron products, oral vitamins containing iron and other oral iron containing supplements (See Section 7.7).
  • Subject has known hypersensitivity and/or intolerance to any of the study products to be administered.
  • Subject has previously been randomised into this study.
  • Subject is currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening, or is receiving other investigational agent(s).
  • Subjects who are pregnant (e.g., positive human chorionic gonadotropin test) or breastfeeding.
  • Subjects of childbearing potential, not using adequate contraceptive precautions must agree to use a highly effective method of birth control during the study and for 1 month after the last dose of study medication.
  • Subject has a history of drug or alcohol abuse within 2 years prior to screening.
  • Subject has a significant medical conditions or anticipated need for major surgery during the study, which (in the Investigator's opinion), may be associated with increased risk to the subject, or may interfere with study assessments or outcomes, or the ability to provide informed consent or comply with study procedures.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Southern Medical University Nanfang Hospital

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 and Sevelamer Carbonate (Renvela®) in Chinese CKD Patients With Hyperphosphataemia

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.

Read the detailed description

Primary Objective is to evaluate 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. In addition , secondary objectives include evaluating the efficacy of PA21 and sevelamer carbonate over time as the percentage of subjects with serum phosphorus within the target range of 1.13 to 1.78 mmol/l (3.5 to 5.5 mg/dl) and to compare the safety and tolerability of PA21 versus sevelamer carbonate (Renvela®).

In total, 286 patients (143 patients to PA21 treatment and 143 patients to sevelamer carbonate treatment) will be randomised with a screening period: up to 4 weeks and a washout period of up to 3 weeks. Treatment period (total duration 12 weeks) will include a dose titration period and a maintenance period of an open-label, active-controlled comparison of PA21 versus sevelamer carbonate for 4 weeks. The primary efficacy assessment will be a non-inferiority assessment of the 2 groups of subjects at Week 12 in terms of serum phosphate lowering capability. There will be a follow-up period of 30 days after last dosing.

The investigational treatments will be a PA21 dose group of PA21 chewable tablets standardised to contain 500 mg of iron. PA21 contains approximately 20% m/m of elemental iron. All doses of PA21 are expressed in mg of iron. The 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 , provided a subject has been receiving that dose for a minimum of 2 weeks and for safety or tolerability reasons at any time. 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). The active control is sevelamer carbonate, Renvela®, tablets, containing 800 mg of sevelamer carbonate. The 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)) are permitted, provided a subject has been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time. 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).

Being tested
PA21, sevelamer carbonate
Keywords
Chronic Kidney Disease, Hyperphosphatemia, Dialysis
Medical subject headings
Hyperphosphatemia, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PA21Drug

    Also called sucroferric oxyhydroxide, Velphoro®

    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.

  • sevelamer carbonateDrug

    Also called Renvela®

    sevelamer carbonate tablets containing 800 mg of sevelamer carbonate.

Study groups in NCT03644264
Study groupRoleWhat they receive
PA21 tablets containing 500 mg of ironExperimentalPA21 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).
Receives: Drug: PA21
Sevelamer carbonate: Renvela® tabletsActive comparatorStarting 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).
Receives: Drug: sevelamer carbonate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum phosphorus (mmol/l )

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

    Measured: baseline and 12 weeks

Secondary outcomes (12)

  1. Serum phosphorus (mmol/l )

    Serum phosphorus levels at each time point and change from baseline (BL)

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

  2. Serum phosphorus (mmol/l)

    % of subjects with serum phosphorus within 1.13 to 1.78 mmol/l

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

  3. Adverse events (AEs)

    Frequency of AEs determined by seriousness, severity and relatedness to study drugs

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

  4. Diarrhoea.

    Frequency of AE of special interest - diarrhoea.

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

  5. Withdrawals due to AEs

    Percentage of withdrawals due to AEs

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

  6. Serum calcium (mmol/l)

    Serum total calcium levels at each time point and change from baseline

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

  7. Hypercalcemia (mmol/l)

    Percentage of subjects that develop at least 1 episode of sustained hypercalcaemia (>10.0 mg/dl; >2.5 mmol/l) during study participation

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

  8. Serum iPTH (pg/ml)

    Serum iPTH levels at specified time points and change from baseline

    Measured: baseline, weeks 8, 12

  9. Serum iron (mcg/dl)

    Serum iPTH levels at specified time points and change from baseline

    Measured: baseline, weeks 4, 8, 12

  10. Serum ferritin (mcg/l)

    Serum ferritin levels at specified time points and change from baseline

    Measured: baseline, weeks 4, 8, 12

  11. Serum transferrin (mcg/dl)

    Serum transferrin measured at specified timepoints

    Measured: baseline, weeks 4, 8, 12

  12. Transferrin saturation (TSAT) (%)

    TSAT measured at specified timepoints

    Measured: baseline, weeks 4, 8, 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2018
  2. Study start31 Aug 2018
  3. Primary completion21 Aug 2020
  4. Study completion21 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-label, Randomised, Active-controlled, Parallel Group, Multicentre,
Masking
None (open label)
Enrolment
286 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03644264
Sponsor's protocol ID
PA-CL-CHINA-01
Status last verified
May 2021
First submitted
21 Aug 2018
Last updated
2 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40576086

  • 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.

    PubMed 37473746

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PA21 and sevelamer carbonate in people with Chronic Kidney Disease Requiring Chronic Dialysis and Hyperphosphatemia, run by Vifor Fresenius Medical Care Renal Pharma at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum phosphorus (mmol/l ) (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03644264, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.

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