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An 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

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ClinicalTrials.gov Identifier: NCT02688764
Recruitment Status : Recruiting
First Posted : February 23, 2016
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Vifor Fresenius Medical Care Renal Pharma

Brief Summary:
This 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).

Condition or disease Intervention/treatment Phase
Hyperphosphatemia Drug: PA21 (Velphoro®) Drug: Calcium Acetate (Phoslyra®) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: PA21 (Velphoro®)

PA21 (Velphoro®), chewable tablets 500 mg iron

PA21 (Velphoro®), chewable tablets 250 mg iron

PA21 (Velphoro®), powder for oral suspension 500 mg iron

PA21 (Velphoro®), powder for oral suspension 250 mg iron

PA21 (Velphoro®), powder for oral suspension 125 mg iron

Drug: PA21 (Velphoro®)

During Stage 1 (Open-Label Dose Titration; up to 10 weeks), PA21 subjects will receive PA21 at a starting dose based on their age. Dose of PA21 will be increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject has been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time.

During Stage 2 (Open-Label Safety Extension, 24 week safety extension),subjects will continue on the dose received at the end of Stage 1, unless a dose change is required. Doses may be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject has been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time during Stage 2.

Other Name: sucroferric oxyhydroxide
Active Comparator: Calcium Acetate (Phoslyra®)
Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL.
Drug: Calcium Acetate (Phoslyra®)

During Stage 1 (Open-Label Dose Titration; up to 10 weeks), Phoslyra subjects will receive Phoslyra either at a starting dose based on their weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose of Phoslyra will be increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject has been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time.

During Stage 2 (Open-Label Safety Extension, 24 week safety extension),subjects will continue on the dose received at the end of Stage 1, unless a dose change is required. Doses may be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject has been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time during Stage 2.




Primary Outcome Measures :
  1. Change in serum phosphorus from baseline in the PA21 group [ Time Frame: At the end of Stage 1 (up to 10 weeks after randomization) ]

Secondary Outcome Measures :
  1. Change in serum phosphorus from baseline in the Phoslyra group [ Time Frame: At end of Stage 1 (up to 10 weeks after randomization) ]
  2. Change in serum phosphorus from baseline in the PA21 group [ Time Frame: through study completion, an average of 34 weeks ]
  3. Change in serum phosphorus from baseline in the Phoslyra group [ Time Frame: through study completion, an average of 34 weeks ]
  4. Percentage of subjects in each stage during which the subject has serum phosphorus levels in the age dependent target ranges. [ Time Frame: through study completion, an average of 34 weeks ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688764


Contacts
Contact: Sven Knapinski, PhD +41588518261 Sven.Knapinski@viforpharma.com

  Show 35 Study Locations
Sponsors and Collaborators
Vifor Fresenius Medical Care Renal Pharma
Investigators
Principal Investigator: Larry A Greenbaum, MD; PhD Children's Healthcare of Atlanta at Egleston

Responsible Party: Vifor Fresenius Medical Care Renal Pharma
ClinicalTrials.gov Identifier: NCT02688764     History of Changes
Other Study ID Numbers: PA-CL-PED-01
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017

Keywords provided by Vifor Fresenius Medical Care Renal Pharma:
PA21
phosphate binder

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases
Calcium, Dietary
Calcium acetate
Ferric Compounds
Bone Density Conservation Agents
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Hematinics