A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis

NCT00833768 | Terminated Phase 3

• 2 other identifiers: SVCARB00606Eudra CT: 2007-003885-16
• Study Type: interventional
• Target: 5
• Locations: 9 countries
• Sites: 36

Brief Summary

Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 European countries. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is a safe and effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 24 weeks.

Conditions

Chronic Kidney Disease; Hyperphosphatemia

Outcome Measures

Primary Outcomes (1)

• To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum phosphorus levels

  24 weeks

Secondary Outcomes (2)

• To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum total cholesterol and low density lipoprotein (LDL) cholesterol

  24 weeks

• To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum corrected calcium-phosphorus product (CaxP)

  24 weeks

Study Arms (2)

Sevelamer carbonate

ACTIVE COMPARATOR

Drug: Sevelamer carbonate

Placebo

PLACEBO COMPARATOR

Drug: Placebo for sevelamer carbonate

Interventions

Sevelamer carbonate DRUG

800mg tablets to be taken orally with meals three times per day

Also known as: Renvela(TM)

Sevelamer carbonate

Placebo for sevelamer carbonate DRUG

Placebo tablets to be taken orally with meals three times per day

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Serum phosphorus measurement ≥4.6 mg/dL (≥1.49 mmol/L) and ≤5.5 mg/dL (≤1.76 mmol/L after discontinuation of current phosphate binder therapy if applicable.

You may not qualify if:

• Active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (36)

Universitätsklinik für Innere Medizin, Klinische Abteilung für Nephrologie und Hämodialyse

Graz, Austria

Location

Uniklinik für Innere Medizin IV, Nephrologie und Hypertensiologie, Zentrum für Innere Medizin, Medizinische Universität Innsbruck

Innsbruck, Austria

Location

Krankenhaus der Elisabethinen Linz, 3. Abteilung Schwerpunkt Nephrologie

Linz, Austria

Location

Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie und Dialyse

Vienna, Austria

Location

CHU Amiens Sud Service de Néphrologie

Amiens, France

Location

Hôpital Pellegrin Service de Néphrologie

Bordeaux, France

Location

Hôpital Européen G. Pompidou Département de Physiologie - Explorations Fonctionnelles et Radio-Isotopes

Cedex, France

Location

Service de Néphrologie Hémodialyse Clinique de l'Orangerie

Cedex, France

Location

Hôpital La Peyronie Nephrologie

Montpellier, France

Location

Hôpital Tenon Néphrologie Hémodialyse

Paris, France

Location

CHU de Brabois, Service de Néphrologie

Vandœuvre-lès-Nancy, France

Location

Klinikum Darmstadt

Darmstadt, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Klinikum rechts der Isar der TU München, Nephrologie

München, Germany

Location

Ippokrateio Hospital of Athens

Athens, Greece

Location

University Hospital of Ioannina

Ioannina, Greece

Location

General Hospital of Nikaia

Nikaia Peiraias, Greece

Location

Petz Aladár County Teaching hospital, Department ofimmunonephrology and hypertension

Győr, Hungary

Location

Kaposi Mór County Hospital Department of Nephrology

Kaposvár, Hungary

Location

Szekszárd EuroCare Dialysis Centre Number 7

Szekszárd, Hungary

Location

Kórház u. 1

Veszprém, Hungary

Location

Azienda Ospedaliera di Lecco

Lecco, Italy

Location

Fondazione Salvatore Maugeri, Divisione Nefrologia ed Emodialisi

Pavia, Italy

Location

Unita' Operativa Complessa Di Nefrologia e Dialisi San Camillo Forlanini

Roma, Italy

Location

Hospital Santa Cruz

Carnaxide, Portugal

Location

Centro Hospitalar de Coimbra - Serviço de Nefrologia

Coimbra, Portugal

Location

Hospital da Universidade de Coimbra - Serviço de Nefrologia, Av.

Coimbra, Portugal

Location

Hospital de São João EPE - Serviço de Nefrologia

Porto, Portugal

Location

Servicio de nefrología Fundacion Puigvert

Barcelona, Spain

Location

Servicio de nefrología H. Arquitecto Marcide

Ferrol, Spain

Location

Servicio de nefrología Hospital de Galdakao

Galdakao, Spain

Location

Servicio de nefrología Fundación Hospital Alcorcón

Madrid, Spain

Location

Servicio de Nefrología, Hospital Universitario Dr Peset,

Valencia, Spain

Location

Department of Nephrology Sahlgrenska University Hospital

Gothenburg, Sweden

Location

NjurmedicinKliniken Centralsjukhuset

Karlstad, Sweden

Location

Njurmedicinska Kliniken, Karolinska Universitetssjukhuset, Solna

Stockholm, Sweden

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperphosphatemia

Interventions

Sevelamer

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: February 2, 2009
• Study Start: January 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

SE (3); DE (3); IT (3); GR (3); PT (4); HU (4); ES (5); AU (4); FR (7)