Status:
COMPLETED
Sirolimus Therapy for Poor Prognosis Immunoglobulin A Nephropathy
Lead Sponsor:
Josep m Cruzado
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Glomerulonephritis, IGA
Nephropathy, IGA
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00396721
Start Date
January 1 2006
End Date
February 1 2010
Last Update
September 16 2011
Active Locations (1)
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1
Nephrology Department. Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907