A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis

PHASE2CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

February 15, 2013

Primary Completion Date

November 16, 2018

Study Completion Date

November 16, 2018

Conditions
Chronic Kidney DiseaseHyperphosphatemia
Interventions
DRUG

Lanthanum Carbonate

Lanthanum Carbonate 1500 mg to 3000 mg powder will be administered orally.

DRUG

Calcium Carbonate

Calcium carbonate will be administered orally at a total daily dose based on standard clinical practice. The total daily dose may be adjusted as appropriate, until the target serum phosphorus level is achieved or until a maximum daily dose of 6500 mg is reached.

Trial Locations (22)

1083

Semmelweis Egyetem Altalanos Orvostudomanyi Kar, Budapest

4000

Centro Infantil Del Rinon S.R.L, San Miguel de Tucumán

4032

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Debrecen

4500

Izmir Tepecik Training and Research Hospital, Izmir

6720

Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar, Szeged

15006

University Hospital Motol, Prague

30625

Medizinische Hochschule Hannover, Hanover

30663

Uniwersytecki Szpital Dzieciecy w Krakowie, Klinika Nefrologii Dzieciecej ze Stacja Dializ, Krakow

45030

Manisa Celal Bayar University Hafsa Sultan Hospital, Manisa

50556

Uniwersytecki Szpital Kliniczny, Wroclaw

70852

Fakultni nemocnice Ostrava, Ostrava

91054

Kinder-und Jugendklinik Erlangen, Erlangen

107014

Children City Clinical Hospital of Saint Vladimir, Moscow

198205

"Saint-Petersburg State Budgetary Healthcare Institution Children City Hospital #1", Saint Petersburg

300350

Spitalul Clinic de Urgenta pentru Copii - Louis Turcanu, Timișoara

620143

"State Budgetary Healthcare Instit. of Sverdiov Region Regional Children Clinical Hosp #1", Yekaterinburg

7500539

Hospital Luis Calvo Mackenna, Santiago

8207257

Hospital Dr. Sotero del Rio, Santiago

15-274

Uniwersytecki Dzieciecy Szpital Kliniczny, Bialystok

93-338

NZOZ tri-Medica, Lodz

Unknown

Spitalul Clinic de Urgenta pentru Copii Sf. Maria, Iași

01330

Cukurova University Faculty of Medicine Paediatric Nephrology, Adana

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT01696279 - A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis | Biotech Hunter | Biotech Hunter