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A Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent Chronic Kidney Disease (CKD) Patients With Hyperphosphataemia | Clinical Trials | Clareo Health

TERMINATEDPHASE3

A Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent Chronic Kidney Disease (CKD) Patients With Hyperphosphataemia

An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients With Hyperphosphataemia

NCT02688764•Vifor Fresenius Medical Care Renal Pharma

View on ClinicalTrials.gov

Summary

This is a Phase 3, Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients with Hyperphosphataemia. The aim of this Phase 3 clinical study is to demonstrate similar efficacy of PA21 (Velphoro) in paediatric and adolescent patients with CKD, and to provide safety and dosing information for this patient population. The Phoslyra (comparator) group provides information for a descriptive comparison of PA21 against a commonly used calcium-based phosphate binder (calcium acetate).

Eligibility

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects 0 to \<18 years at time of consent.
•2. Subjects with hyperphosphataemia
•3. Subjects ≥1 year with CKD Stages 4-5 defined by a glomerular filtration rate \<30 mL/min/1.73 m2 or with CKD Stage 5D receiving adequate maintenance haemodialysis (HD) or peritoneal dialysis (PD) for at least 2 months prior to screening.
•4. Subjects \<1 year must have CKD.
•5. Appropriate written informed consent and, where appropriate/required assent, have been provided.

Exclusion Criteria

•1. Subjects with hypercalcaemia at screening
•2. Subjects with intact parathyroid hormone (iPTH) levels \>700 pg/mL at screening.
•3. Subjects who are PB naïve who weigh \<5 kg at screening. Subjects receiving stable doses of PBs who weigh \<6 kg at screening
•4. Subjects requiring feeding tube sizes ≤6 FR (French catheter scale).
•5. Subjects with history of major gastrointestinal surgery or significant gastrointestinal disorders.
•6. Subjects with hypocalcaemia (serum total corrected calcium \<1.9 mmol/L; \<7.6 mg/dL) at screening.
•7. Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding.
•8. Subject has a significant medical condition(s)

Locations (38)

University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

University of Miami - Miller School of Medicine

Miami, Florida, United States

Nicklaus Children's Hospital

Miami, Florida, United States

Nemours Children's Clinic - Orlando

Orlando, Florida, United States

Emory-Children's Center

Atlanta, Georgia, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of Michigan Hospital

Ann Arbor, Michigan, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Key Dates

Start Date

May 26, 2016

Primary Completion Date

February 21, 2019

Completion Date

February 21, 2019

Last Updated

September 10, 2019

Enrollment

ACTUAL participants

Conditions

Hyperphosphatemia

Interventions

PA21 (Velphoro®)

DRUG

Calcium Acetate (Phoslyra®)

DRUG

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

NCT06933472

HyperphosphatemiaChronic Kidney Disease, Receiving Dialysis+2 more

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COMPLETEDPHASE3

Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease

NCT05085275

Anemia, Iron DeficiencyHyperphosphatemia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent Chronic Kidney Disease (CKD) Patients With Hyperphosphataemia

Inclusion Criteria

Exclusion Criteria

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease

Long-term Effects of the New Nordic Renal Diet in Patients With Moderate Chronic Kidney Disease

Rate of Termination of Premixed Parenteral Nutrition (PN) in Surgical Patients Secondary to High Serum Electrolytes

Long-term Effect of Lanthanum Carbonate on Bone

Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients