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Pilot Trial of Treatment of Poor-Prognosis Iga Nephropathy With Low Exposure to Sirolimus.
This study is currently recruiting participants.
Verified by Hospital Universitari de Bellvitge, November 2006
Sponsors and Collaborators: Hospital Universitari de Bellvitge
Wyeth
Information provided by: Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT00396721
  Purpose

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: sirolimus
Phase II

Drug Information available for: Sirolimus
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Pilot Trial of Treatment of Poor-Prognosis Iga Nephropathy With Low Exposure to Sirolimus.

Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • To evaluate the effect at month 12th 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

Secondary Outcome Measures:
  • Change in the glomerular filtrate rate evaluated by means of radionuclide techniques (51Cr-EDTA) at months 6th and 12th, and comparison between both arms
  • Change in renal histology at 12 months
  • Percentage of patients who withdraw from the study medication due to adverse events
  • Percentage of patients with therapeutic failure

Estimated Enrollment: 20
Study Start Date: January 2006
Estimated Study Completion Date: November 2006
  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 immunochistochemical 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 Cockroft-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 wit 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 lactancy at the time of inclusion in the study
  • Estimated glomerular filtration < 30 ml/min, bilirrubine > 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 glucaemias 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 inthe previous 5 years,exception of skin basocellular carcinoma and uterine in situ carcinoma (comletely removed both of them)
  • Know intolerance to Sirolimus or macrolids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396721

Contacts
Contact: Josep M. Cruzado, Medical Doctor 0034932607602 27541jcg@comb.es

Locations
Spain, Barcelona
Nephrology Department. Hospital Universitari de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Josep M Cruzado, Medical Doctor     0034932607602     27541jcg@comb.es    
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Wyeth
Investigators
Study Chair: Josep M Cruzado, Medical Doctor Nephrlogy Department. Hospital Universitari de Bellvitge
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: SIREPNA/05, 2005-002610-37
Study First Received: November 3, 2006
Last Updated: November 20, 2006
ClinicalTrials.gov Identifier: NCT00396721  
Health Authority: Spain: Ministry of Health

Keywords provided by Hospital Universitari de Bellvitge:
Nephropathy, IGA
Pilot trial
Sirolimus
Rapamune

Study placed in the following topic categories:
Sirolimus
Glomerulonephritis
Autoimmune Diseases
Urologic Diseases
Clotrimazole
Miconazole
Nephritis
Tioconazole
Berger disease
Glomerulonephritis, IGA
Kidney Diseases

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Antifungal Agents
Therapeutic Uses
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009