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Effects of an Intensified Treatment With ACE-I,ATA II and Statins in Alport Syndrome

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ClinicalTrials.gov Identifier: NCT00309257
Recruitment Status : Completed
First Posted : March 31, 2006
Last Update Posted : October 6, 2009
Sponsor:
Information provided by:

Study Description
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 constituent of basement membranes in renal glomeruli. Renal impairment occurs with time and severe renal failure with hypertension and uremia represent the end stage of the disease, even if a high variability in the rate of progression is described.Males are usually affected by a progressive form of the disease. Affected females with X-linked syndrome usually have a good prognosis with a mild renal impairment. The disease is also associated to a sensor neural deafness which can occur in approximately half of the patient affected and usually correlates with renal impairment. No definite treatment exists in order to delay the time of dialysis or a kidney transplant. Many studies showed that Angiotensin converting enzyme (ACE) inhibitors slow glomerular filtration rate (GFR) decline and limit progression to end stage renal disease (ERDS) and dialysis in several chronic nephropathies associated with proteinuria. The combination of ACE-I with Angiotensin II receptor antagonists may reduce proteinuria more effectively than the two drugs alone. Moreover the addition of statins may synergize the antiproteinuric effects of ACE-I and ATAII antagonists in experimental models of chronic renal diseases.

The purpose of this study is to evaluate the effect of a standardized multimodal nephroprotection intervention (Remission Clinic) in Alport patients with renal involvement.


Condition or disease Intervention/treatment Phase
Alport Syndrome Drug: ACE I, ATA II and Statins Drug: Benazepril, Valsartan and Fluvastatin Phase 2

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of an Intensified Treatment With ACE-inhibitors, Angiotensin II Receptor Antagonists and Statins in Alport Syndrome
Study Start Date : January 2004
Primary Completion Date : June 2008
Study Completion Date : October 2009

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ACE inhibitor, ATA II antagonists and Statins Drug: ACE I, ATA II and Statins Drug: Benazepril, Valsartan and Fluvastatin

Patients will be given a low dose of Benazepril, 10 mg/die,that, if tolerated, will be up-titrated, after a week,to 20 mg/day.

Patients will be given Valsartan, 80 mg/die,up-titrated after a week to 160 mg/die. Fluvastatin will be started at 40 mg/die.If tolerated, will up-titrated to 80 mg/die. In case of liver, muscular or renal toxicity, fluvastatin will be back-titrated to 40 mg or withdrawn as deemed appropriate.



Outcome Measures

Primary Outcome Measures :
  1. Urinary protein excretion [ Time Frame: At baseline and monthly ]

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: At baseline, monthly and when deemed clinically appropriate ]
  2. Urinary podocyte excretion [ Time Frame: At baseline and every six months. ]

Eligibility Criteria

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309257


Locations
Italy
Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy, 24020
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Investigators
Principal Investigator: Erica Daina, MD Mario Negri Institute for Phrmacological Research
More Information

Responsible Party: Mario Negri Institute for Pharmacological Research, Clinical Research Center for Rare Diseases Aldo and Cele Daccò
ClinicalTrials.gov Identifier: NCT00309257     History of Changes
Other Study ID Numbers: FVA01
First Posted: March 31, 2006    Key Record Dates
Last Update Posted: October 6, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Syndrome
Nephritis, Hereditary
Disease
Pathologic Processes
Urogenital Abnormalities
Nephritis
Kidney Diseases
Urologic Diseases
Congenital Abnormalities
Collagen Diseases
Connective Tissue Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Fluvastatin
Benazepril
Valsartan
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Protease Inhibitors