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



Status:Recruiting
Healthy:No
Age Range:Any - 18
Updated:10/17/2018
Start Date:June 2016
End Date:August 2019
Contact:Sven Knapinski, PhD
Email:Sven.Knapinski@viforpharma.com
Phone:+41588518261

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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

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).


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)
We found this trial at
23
sites
94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Principal Investigator: Shefali Vyas
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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Livingston, NJ
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
Principal Investigator: Caroline Abitbol
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Miami, FL
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1717 South Orange Avenue # 100
Orlando, Florida 32806
(407) 650-7000
Principal Investigator: Robert Mathias
Nemours Children's Clinic - Orlando Located near downtown Orlando, Nemours Children’s Clinic, Orlando is a...
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Orlando, FL
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Benjamin Laskin
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Craig Wong
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Albuquerque, NM
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Ann Arbor, Michigan 48109
Principal Investigator: Larysa Wickman
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Ann Arbor, MI
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Atlanta, Georgia 30322
Principal Investigator: Larry A. Greenbaum, MD, PhD
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Atlanta, GA
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Birmingham, AL
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Mouin Seikaly
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dallas, TX
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Shashi Nagaraj
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Kenneth Lieberman
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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1102 Bates Avenue
Houston, Texas 77030
Principal Investigator: Sarah Swartz
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Houston, TX
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Houston, Texas 77030
Principal Investigator: Rita Swinford
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Houston, TX
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Jason Misurac
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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Lille, 59000
Principal Investigator: Annie Lahoche
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Lille,
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Miami, Florida 33155
Principal Investigator: Ana Paredes
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Miami, FL
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Principal Investigator: Rajasree Sreedharan
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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Milwaukee, WI
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New York, New York 10021
Principal Investigator: Eduardo Perelstein
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New York, NY
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Oklahoma City, Oklahoma 73104
Principal Investigator: Pascale Lane
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Oklahoma City, OK
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Portland, Oregon 97239
Principal Investigator: Amira Al-Uzri
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Portland, OR
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Principal Investigator: Keith Hruska
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Saint Louis, MO
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Salt Lake City, Utah 84143
Principal Investigator: Raoul Nelson
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Salt Lake City, UT
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Sun Young Ahn
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington,
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