NCT01857024

Brief Summary

The primary objective of this study is to assess in a post-approval clinical setting the safety profile of sevelamer carbonate (Renvela®) tablets and powder in adult hyperphosphataemic chronic kidney disease (CKD) patients not on dialysis with serum phosphorus ≥1.78 mmol/L. Patients will be treated in accordance with the Renvela® Summary of Product Characteristics (SmPC) and followed according to the investigator's standard clinical practice management. Each patient will be followed up for 12 months or up to the time they start dialysis, whichever occurs first.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

Geographic Reach
7 countries

26 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

September 1, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
Last Updated

March 23, 2015

Status Verified

March 1, 2015

Enrollment Period

2.1 years

First QC Date

May 13, 2013

Last Update Submit

March 19, 2015

Conditions

HyperphosphataemiaChronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Frequency of non-serious and Serious Adverse Drug Reaction (ADRs)

    Assess safety profile of Renvela tablets and powder

    12 Months

Interventions

sevelamer carbonate (Renvela®)DRUG

800 mg tablets or 2.4 g powder for oral suspension should be administered as instructed in the Renvela® SmPC.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult Chronic Kidney Disease (CKD) patients not on dialysis with serum phosphorus ≥ 1.78 mmol/L.

You may qualify if:

  • Adult Chronic Kidney Disease (CKD) patients not on dialysis with serum phosphorus ≥ 1.78 mmol/L.
  • Prescribed Renvela (800 mg tablets or 2.4 g powder for oral suspension) in accordance with the Renvela SmPC.
  • Provide signed informed consent (patient or their legally authorised representative)

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Unknown Facility

Graz, Austria

Location

Unknown Facility

Linz, Austria

Location

Unknown Facility

Aalborg, Denmark

Location

Unknown Facility

Cabestany, France

Location

Unknown Facility

Dijon, France

Location

Unknown Facility

Lille, France

Location

Unknown Facility

Saint-Laurent-du-Var, France

Location

Unknown Facility

Toulouse, France

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Dortmund, Germany

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Mettmann, Germany

Location

Unknown Facility

Wiesbaden, Germany

Location

Unknown Facility

Acireale, Italy

Location

Unknown Facility

Milan, Italy

Location

Unknown Facility

Naples, Italy

Location

Unknown Facility

Palermo, Italy

Location

Unknown Facility

Pavia, Italy

Location

Unknown Facility

Pesaro, Italy

Location

Unknown Facility

Rome, Italy

Location

Unknown Facility

Amsterdam, Netherlands

Location

Unknown Facility

Breda, Netherlands

Location

Unknown Facility

Dordrecht, Netherlands

Location

Unknown Facility

Leiden, Netherlands

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Valencia, Spain

Location

MeSH Terms

Conditions

HyperphosphatemiaRenal Insufficiency, Chronic

Interventions

Sevelamer

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesRenal 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
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 20, 2013

Study Start

September 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 23, 2015

Record last verified: 2015-03

Locations

AU(2)FR(5)IT(7)NL(4)ES(2)DE(5)DK(1)