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Sirolimus Therapy for Poor Prognosis Immunoglobulin A Nephropathy

NCT00396721 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2011-09-16

No results posted yet for this study

Summary

The purpose of this study is to test in a pilot trial the efficacy and tolerance of sirolimus oral (at low doses) in patient to treat poor-prognosis IgA Nephropathy.

Conditions

Interventions

DRUG

ACE inhibitor + statin

sirolimus starting at 1 mg/d (target 3-6 ng/ml) plus enalapril starting at 5 mg/d to control blood pressure plus atorvastatin starting at 10 mg/d

DRUG

Sirolimus (study drug)+ACE inhibitor + statin

enalapril starting at 5 mg/d in order to control blood pressure. Atorvastatin starting at 10 mg/d

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Josep m Cruzado

    lead OTHER

Principal Investigators

  • Josep M Cruzado, Medical Doctor · Nephrlogy Department. Hospital Universitari de Bellvitge

  • Meritxell Ibernon, MD · Germans Trias i Pujol Hospital

  • JORDI BALLARÍN, MD · FUNDACIÓ PUIGVERT DE BARCELONA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2009-10-31
Completion
2010-02-28

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00396721 on ClinicalTrials.gov