Sirolimus Therapy for Poor Prognosis Immunoglobulin A Nephropathy
Pilot Trial of Treatment of Poor-Prognosis IgA Nephropathy With Low Exposure to Sirolimus.
  • Phase

    Phase 2
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

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 Started
Jan 31
Primary Completion
Oct 31
Study Completion
Feb 28
Last Update
Sep 16

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

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

A Active Comparator


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
No Results Posted