Sirolimus Therapy for Poor Prognosis Immunoglobulin A Nephropathy (SIREPNA)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00396721 |
Recruitment Status :
Completed
First Posted : November 7, 2006
Last Update Posted : September 16, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glomerulonephritis, IGA Nephropathy, IGA IGA Nephropathy | Drug: ACE inhibitor + statin Drug: Sirolimus (study drug)+ACE inhibitor + statin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pilot Trial of Treatment of Poor-Prognosis IgA Nephropathy With Low Exposure to Sirolimus. |
Study Start Date : | January 2006 |
Actual Primary Completion Date : | October 2009 |
Actual Study Completion Date : | February 2010 |

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 |
- 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 ]
- 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 ]
- Change in renal histology [ Time Frame: At 12 months ]
- Percentage of patients who withdraw from the study medication due to adverse events [ Time Frame: Within 1 year ]
- Percentage of patients with therapeutic failure [ Time Frame: Within 1 year ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396721
Spain | |
Nephrology Department. Hospital Universitari de Bellvitge | |
L'Hospitalet de Llobregat, Barcelona, Spain, 08907 |
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:
Responsible Party: | Josep m Cruzado, Nephrologist, Hospital Universitari de Bellvitge |
ClinicalTrials.gov Identifier: | NCT00396721 |
Other Study ID Numbers: |
SIREPNA/05 2005-002610-37 |
First Posted: | November 7, 2006 Key Record Dates |
Last Update Posted: | September 16, 2011 |
Last Verified: | September 2011 |
Nephropathy, IGA Pilot trial Sirolimus Rapamune |
Kidney Diseases Glomerulonephritis, IGA Glomerulonephritis Urologic Diseases Nephritis Autoimmune Diseases Immune System Diseases Sirolimus Hydroxymethylglutaryl-CoA Reductase Inhibitors Angiotensin-Converting Enzyme Inhibitors Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic |
Antineoplastic Agents Antifungal Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents Protease Inhibitors |