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CompletedNCT00396721SIREPNAUpdated Sep 16, 2011

Sirolimus Therapy for Poor Prognosis Immunoglobulin A Nephropathy

A Phase 2 interventional study of ACE inhibitor + statin and Sirolimus (study drug)+ACE inhibitor + statin in Glomerulonephritis, IGA, Nephropathy, IGA and IGA Nephropathy, sponsored by Josep m Cruzado. Completed at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-09-16.

Sponsored by Josep m Cruzado · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Glomerulonephritis, IGA
  • Nephropathy, IGA
  • IGA Nephropathy

Keywords

  • Nephropathy, IGA
  • Pilot trial
  • Sirolimus
  • Rapamune
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 23 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

This is the only study on the registry with Josep m Cruzado as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Active comparator
    A

    Drug: ACE inhibitor + statin

  • Experimental
    B

    Drug: Sirolimus (study drug)+ACE inhibitor + statin

Interventions

  • DrugACE 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

  • DrugSirolimus (study drug)+ACE inhibitor + statin

    enalapril starting at 5 mg/d in order to control blood pressure. Atorvastatin starting at 10 mg/d

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Change in renal histology

    Time frame: At 12 months

  3. Percentage of patients who withdraw from the study medication due to adverse events

    Time frame: Within 1 year

  4. Percentage of patients with therapeutic failure

    Time frame: Within 1 year

07

Study locations

1 site
  • Nephrology Department. Hospital Universitari de Bellvitge
    L'Hospitalet de Llobregat, Barcelona 08907, Spain
08

References and documents

Publications

  • Donadio JV, Grande JP. IgA nephropathy. N Engl J Med. 2002 Sep 5;347(10):738-48. doi: 10.1056/NEJMra020109. No abstract available. PubMed 12213946 ↗
  • Donadio JV Jr, Bergstralh EJ, Offord KP, Spencer DC, Holley KE. A controlled trial of fish oil in IgA nephropathy. Mayo Nephrology Collaborative Group. N Engl J Med. 1994 Nov 3;331(18):1194-9. doi: 10.1056/NEJM199411033311804. PubMed 7935657 ↗
  • Wu H, Clarkson AR, Knight JF. Restricted gammadelta T-cell receptor repertoire in IgA nephropathy renal biopsies. Kidney Int. 2001 Oct;60(4):1324-31. doi: 10.1046/j.1523-1755.2001.00937.x. PubMed 11576346 ↗
  • Bonegio RG, Fuhro R, Wang Z, Valeri CR, Andry C, Salant DJ, Lieberthal W. Rapamycin ameliorates proteinuria-associated tubulointerstitial inflammation and fibrosis in experimental membranous nephropathy. J Am Soc Nephrol. 2005 Jul;16(7):2063-72. doi: 10.1681/ASN.2004030180. Epub 2005 May 25. PubMed 15917339 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00396721
Lead sponsor
Josep m Cruzado
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Responsible party
Josep m Cruzado (Nephrologist, Hospital Universitari de Bellvitge) — Sponsor-investigator
First posted
Nov 7, 2006
Start date
Jan 2006
Primary completion
Oct 2009
Completion
Feb 2010
Last update
Sep 16, 2011

Study contacts

Josep M Cruzado, Medical Doctor
study chair · Nephrlogy Department. Hospital Universitari de Bellvitge
Meritxell Ibernon, MD
principal investigator · Germans Trias i Pujol Hospital
JORDI BALLARÍN, MD
principal investigator · FUNDACIÓ PUIGVERT DE BARCELONA

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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