Status:
COMPLETED
Effects of an Intensified Treatment With ACE-I,ATA II and Statins in Alport Syndrome
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Alport Syndrome
Eligibility:
All Genders
15-70 years
Phase:
PHASE2
Brief Summary
Alport syndrome (AS) represents a form of progressive hereditary nephritis in which the genetic defect resides in the synthesis of one of several subunits of type IV collagen, the predominant constitu...
Detailed Description
Alport syndrome (AS) represents a form of progressive hereditary nephritis in which the genetic defect resides in the synthesis of one of several subunits of type IV collagen, the predominant constitu...
Eligibility Criteria
Inclusion
- age ≥15 years
- Alport disease
- Creatinine clearance \>20 ml/min/1.73 mq with variation of less than 30% in the three months prior to study entry
- written informed consent. For patients \<18 years old a written informed consent of both parents is needed
Exclusion
- treatment with immunosuppressive drugs in the six months preceding the study
- vascular disease of the kidney
- obstructive uropathy, prostatic hypertrophy, incomplete bladder emptying
- transplanted kidney
- clinically relevant electrolyte imbalance (e.g., hyperkaliemia with serum K+ \> 5.5 mEq/l)
- any concomitant medication with drugs that may directly affect UAE including ACE-inhibitors, angiotensin II receptor antagonists, non dihydropyridine CCBS, HMGCoA reductase inhibitors in the last one month
- history of hypersensitivity to the study drugs
- impossibility to temporary withdrawn ACE-I or ATA II or statins (heart failure, cardiovascular events over the last three months)
- any clinically relevant condition that may affect study participation and/or study results
- pregnancy, ineffective contraception, breast feeding
- inability to fully understand the purposes/risks of the study and/or to provide a written informed consent
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00309257
Start Date
January 1 2004
End Date
October 1 2009
Last Update
April 4 2023
Active Locations (1)
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1
Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy, 24020