Sirolimus Therapy for Poor Prognosis Immunoglobulin A Nephropathy (SIREPNA)
This study has been completed.
Sponsor:
Josep m Cruzado
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Josep m Cruzado, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT00396721
First received: November 3, 2006
Last updated: September 14, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glomerulonephritis, IGA Nephropathy, IGA IGA Nephropathy |
Drug: ACE inhibitor + statin Drug: Sirolimus (study drug)+ACE inhibitor + statin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Trial of Treatment of Poor-Prognosis IgA Nephropathy With Low Exposure to Sirolimus. |
Resource links provided by NLM:
Further study details as provided by Hospital Universitari de Bellvitge:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Change in renal histology [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
- Percentage of patients who withdraw from the study medication due to adverse events [ Time Frame: Within 1 year ] [ Designated as safety issue: Yes ]
- Percentage of patients with therapeutic failure [ Time Frame: Within 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 23 |
| Study Start Date: | January 2006 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396721
Locations
| Spain | |
| Nephrology Department. Hospital Universitari de Bellvitge | |
| L'Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
Sponsors and Collaborators
Josep m Cruzado
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 | HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL |
| Principal Investigator: | JORDI BALLARÍN, MD | FUNDACIÓ PUIGVERT DE BARCELONA |
More Information
Additional Information:
Publications:
| Responsible Party: | Josep m Cruzado, Nephrologist, Hospital Universitari de Bellvitge |
| ClinicalTrials.gov Identifier: | NCT00396721 History of Changes |
| Other Study ID Numbers: | SIREPNA/05, 2005-002610-37 |
| Study First Received: | November 3, 2006 |
| Last Updated: | September 14, 2011 |
| Health Authority: | Spain: Ministry of Health |
Keywords provided by Hospital Universitari de Bellvitge:
|
Nephropathy, IGA Pilot trial Sirolimus Rapamune |
Additional relevant MeSH terms:
|
Glomerulonephritis Glomerulonephritis, IGA Kidney Diseases Nephritis Urologic Diseases Autoimmune Diseases Immune System Diseases Angiotensin-Converting Enzyme Inhibitors Sirolimus Everolimus Hydroxymethylglutaryl-CoA Reductase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Lipid Regulating Agents |
ClinicalTrials.gov processed this record on May 23, 2013