Sirolimus Therapy for Poor Prognosis Immunoglobulin A Nephropathy
NCT00396721
ABOUT THIS STUDY
FOR MORE INFORMATION
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1-800-718-1021
Adult Trials: 18+ Years
- 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
- 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
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| Descriptive Information | ||||||||||
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| Brief Title ICMJE | Sirolimus Therapy for Poor Prognosis Immunoglobulin A Nephropathy | |||||||||
| Official Title ICMJE | Pilot Trial of Treatment of Poor-Prognosis IgA Nephropathy With Low Exposure to Sirolimus. | |||||||||
| 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. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 2 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE | 23 | |||||||||
| Original Enrollment ICMJE | 20 | |||||||||
| Actual Study Completion Date ICMJE | February 2010 | |||||||||
| Actual Primary Completion Date | October 2009 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Spain | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT00396721 | |||||||||
| Other Study ID Numbers ICMJE | SIREPNA/05 2005-002610-37 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | Josep m Cruzado, Hospital Universitari de Bellvitge | |||||||||
| Study Sponsor ICMJE | Josep m Cruzado | |||||||||
| Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
| Investigators ICMJE |
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| PRS Account | Hospital Universitari de Bellvitge | |||||||||
| Verification Date | September 2011 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||