Sirolimus Therapy for Poor Prognosis Immunoglobulin A Nephropathy

NCT00396721

Last updated date
Study Location
Nephrology Department. Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
IGA Glomerulonephritis, IGA Nephropathy, IGA Nephropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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IGA Glomerulonephritis, IGA Nephropathy, IGA NephropathySirolimus Therapy for Poor Prognosis Immunoglobulin A Nephropathy
NCT00396721
  1. L'Hospitalet de Llobregat, Barcelona
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Sirolimus Therapy for Poor Prognosis Immunoglobulin A Nephropathy
Official Title  ICMJE Pilot Trial of Treatment of Poor-Prognosis IgA Nephropathy With Low Exposure to Sirolimus.
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glomerulonephritis, IGA
  • Nephropathy, IGA
  • IGA Nephropathy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: ACE inhibitor + statin
  • Experimental: B
    Intervention: Drug: Sirolimus (study drug)+ACE inhibitor + statin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2011)
23
Original Enrollment  ICMJE
 (submitted: November 3, 2006)
20
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00396721
Other Study ID Numbers  ICMJE SIREPNA/05
2005-002610-37
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Josep m Cruzado, Hospital Universitari de Bellvitge
Study Sponsor  ICMJE Josep m Cruzado
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Chair:Josep M Cruzado, Medical DoctorNephrlogy Department. Hospital Universitari de Bellvitge
Principal Investigator:Meritxell Ibernon, MDGermans Trias i Pujol Hospital
Principal Investigator:JORDI BALLARÍN, MDFUNDACIÓ PUIGVERT DE BARCELONA
PRS Account Hospital Universitari de Bellvitge
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP