Sirolimus Therapy for Poor Prognosis Immunoglobulin A Nephropathy (SIREPNA)

September 14, 2011 updated by: Josep M Cruzado

Pilot Trial of Treatment of Poor-Prognosis IgA Nephropathy With Low Exposure to Sirolimus.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Nephrology Department. Hospital Universitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 70 and with capacity to grant informed consent
  • Biopsy-proven IgA nephropathy by means of standard immunohistochemical and morphological criteria
  • Renal biopsy in the in the 3 months prior to randomization date
  • Absence of known hepatic, cardiac, pulmonary or intestinal disease
  • Glomerular filtrate estimated by Cockcroft-Gault, more than 30 ml/min
  • Any of the following clinical states: a) High blood pressure defined as systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than 90 mmHg associated with proteinuria between 0.3-1 g/day and/or microhematuria. b) Proteinuria higher than 1g/day
  • Women of child-bearing age will follow a suitable contraceptive method, and a negative pregnancy test will be needed before inclusion in the study

Exclusion Criteria:

  • Serology positive for HIV or hepatitis B infection (defined as positive for the HbsAg antigen) or hepatitis C infection (defined as viral RNA detection)
  • Treatment with steroids or immunosuppressors in the two previous years
  • Evidence of active infection at the time of inclusion in the study
  • Pregnancy or breastfeeding at the time of inclusion in the study
  • Estimated glomerular filtration < 30 ml/min, bilirubin > 2 mg/dl, or ALT or AST two times higher than the normal upper limit
  • Diabetes Mellitus, defined as patients treated with insulin or oral antidiabetics or glycemias higher than 140 mg/dl in two or more episodes
  • Poor control of high blood pressure (defined as systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg, taking 3 or more antihypertensives) or evidence or suspicion of renovascular disease
  • Thrombocytopenia less than 100,000 /mm3 or total neutrophil value lower than 2000 /mm3 or triglycerides value > 400 mg/dL (4.6 mmol/L) or cholesterol > 300 mg/dL (7.8 mmol/L) or LDL > 200 mg/dL
  • IgA nephropathy systemic forms, i.e., Schönlein-Henoch purpura, IgA nephropathy secondary forms, post-renal transplant IgA nephropathy recurrences, cases presented in the form of rapidly progressive renal failure and cases with the presence of cellular crescents in more than 50% of the glomeruli will be excluded
  • History of cancer in the previous 5 years,exception of skin basocellular carcinoma and uterine in situ carcinoma (completely removed both of them)
  • Know intolerance to Sirolimus or macrolides

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
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
Experimental: B
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the effect of the administration of Rapamune on a clinical composite variable (change in proteinuria, blood pressure and hematuria) in patients with IgA nephropathy with poor prognosis criteria
Time Frame: at month 12th
at month 12th

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the glomerular filtrate rate evaluated by means of radionuclide techniques (51Cr-EDTA) and comparison between both arms
Time Frame: At months 6th and 12th
At months 6th and 12th
Change in renal histology
Time Frame: At 12 months
At 12 months
Percentage of patients who withdraw from the study medication due to adverse events
Time Frame: Within 1 year
Within 1 year
Percentage of patients with therapeutic failure
Time Frame: Within 1 year
Within 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Josep M Cruzado

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Study Chair: Josep M Cruzado, Medical Doctor, Nephrlogy Department. Hospital Universitari de Bellvitge
  • Principal Investigator: Meritxell Ibernon, MD, Germans Trias I Pujol Hospital
  • Principal Investigator: JORDI BALLARÍN, MD, FUNDACIÓ PUIGVERT DE BARCELONA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

November 3, 2006

First Submitted That Met QC Criteria

November 3, 2006

First Posted (Estimate)

November 7, 2006

Study Record Updates

Last Update Posted (Estimate)

September 16, 2011

Last Update Submitted That Met QC Criteria

September 14, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIREPNA/05
  • 2005-002610-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glomerulonephritis, IGA

Clinical Trials on ACE inhibitor + statin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe