NCT00196755

Brief Summary

The purpose of this study is to demonstrate that sevelamer hydrochloride is non-inferior to calcium acetate for the treatment of hyperphosphataemia in patients receiving peritoneal dialysis.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_3

Geographic Reach
7 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

September 15, 2005

Last Update Submit

March 17, 2015

Conditions

Peritoneal DialysisChronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Compare the effects of sevelamer dosed three times per day (TID) and calcium acetate dosed TID on serum phosphorus.

    12 weeks

Secondary Outcomes (3)

  • Serum calcium- phosphorus (CaxPO4) product

    12 weeks

  • Serum lipids - total and LDL cholesterol, non- HDL cholesterol, HDL, triglycerides

    12 weeks

  • Plasma biomarkers: random blood glucose, glycosylated haemoglobin, bone specific alkaline phosphatase, uric acid and c-reactive protein

    12 weeks

Study Arms (2)

Sevelamer Hydrochloride (Renagel®)

EXPERIMENTAL
Drug: Sevelamer Hydrochloride (Renagel®)

Calcium acetate (PhosLo® )

ACTIVE COMPARATOR
Drug: Calcium acetate (PhosLo® )

Interventions

Sevelamer Hydrochloride (Renagel®)DRUG

Sevelamer hydrochloride three times per day with each meal

Sevelamer Hydrochloride (Renagel®)
Calcium acetate (PhosLo® )DRUG

Calcium acetate three times per day with each meal

Calcium acetate (PhosLo® )

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to sign an informed consent form.
  • Men or women aged 18 years of age or older.
  • A diagnosis of Chronic Kidney Disease (CKD) and receiving peritoneal dialysis (Continuous cyclical peritoneal dialysis (CAPD), Automated peritoneal dialysis (APD) or Continuous cyclical peritoneal dialysis (CCPD) for 8 weeks or longer.
  • In the opinion of the investigator, expected to receive peritoneal dialysis for the duration of the study.
  • Will have a serum phosphorus level \>1.76 mmol/L(5.50 mg/dL) after 2 weeks washout from their usual phosphate binder.
  • Will have serum calcium measurement adjusted for albumin within the range (2.10-2.60 mmol/L (8.40-10.40 mg/dL) following 2 weeks washout from their usual phosphate binder.
  • Willing to maintain the prescribed sevelamer or calcium acetate for the duration of the study.
  • Considered compliant with phosphate binders and dialysis.
  • On a stable doses of medication to treat hyperparathyroidism (Vitamin D or its analogues or calcimimetic agents) for the month prior to screening.
  • Willing to discontinue use of antacids containing calcium, aluminium or magnesium at screening visit for the duration of the study (unless taken as an evening calcium supplement as prescribed by the investigator per protocol).
  • Willing to avoid intentional changes in diet such as fasting or dieting.
  • If female and of childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or Intrauterine devices (IUDs).
  • Have a level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel.

You may not qualify if:

  • Patients with a history of peritonitis in the last 30 days or \> 2 episodes in the last 12 months
  • Patient with active dysphagia, swallowing disorder, bowel obstruction, or severe gastrointestinal motility disorder.
  • Patients who in the opinion of the investigator have poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, Human Immunodeficiency Virus (HIV) infection, or any clinically significant, unstable medical condition.
  • Current use of an antiarrhythmic medication such as quinidine, procainamide, tocainide, or amiodarone for the control of arrhythmias.
  • Current use of a seizure medication such as phenytoin, phenobarbital, valproate, or carbamazepine for the control of a seizure disorder.
  • Active ethanol or drug abuse, excluding tobacco use.
  • If female, are pregnant, planning on becoming pregnant in the next 6 months or breast-feeding.
  • Patients with a known hypersensitivity to sevelamer or any constituents of either study drug.
  • Patients who have participated in a study of an investigational drug/device during the 30 days preceding the start of the screening period.
  • Patients who have any other condition, which in the opinion of the investigator will prohibit the patient's participation in the study.
  • Patient is unable to comply with the requirements of the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

UZ Gasthuisberg

Leuven, B-3000, Belgium

Location

Aarhus University Hospital

Århus N, DN-8200, Denmark

Location

Fredericia Sygehus

Fredericia, DN-7000, Denmark

Location

Copenhagen University Hospital

Herlev, DN-2730, Denmark

Location

CHRU Clémenceau

Caen, FR-14033, France

Location

Ospedale civico e benfratelli

Palermo, IT-90127, Italy

Location

Ospedale San Bortolo

Vicenza, IT-36100, Italy

Location

AMC

Amsterdam, NL-1105 AZ, Netherlands

Location

Fundacion Jimenez Diaz

Madrid, ES-28040, Spain

Location

Hospital Universitario La Paz

Madrid, ES-28046, Spain

Location

University Hospital ,Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

High Wycombe Hospital

Buckinghamshire, HP11 2TT, United Kingdom

Location

University of Wales College of Medicine

Cardiff, CF 14 4XN, United Kingdom

Location

Glasgow Western Infirmary

Glasgow, G11 6NT, United Kingdom

Location

Royal Hospital The Royal London

London, E1 1BB, United Kingdom

Location

Milton Keynes General Hospital

Milton Keynes, MK6 5LD, United Kingdom

Location

The Churchill Hospital, Oxford Radcliffe Hospitals NHS Trust

Oxford, OX3 7LJ, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Sevelamercalcium acetate

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic Chemicals

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 20, 2005

Study Start

December 1, 2004

Primary Completion

March 1, 2006

Study Completion

April 1, 2006

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

FR(1)IT(2)DK(3)NL(1)ES(2)BE(1)GB(7)