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Optimalization of Nephroprotection Using Atorvastatin (Sortis)

This study has been completed.
Sponsor:
Information provided by:
Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT00572312
First received: December 12, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

The main purpose of the study is find whether the addition of statin (Atorvastatin) to dual renin-angiotensin-aldosterone system blockade involving angiotensin converting enzyme inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction of proteinuria, main prognostic marker of chronic kidney disease progression.


Condition Intervention
Chronic Kidney Disease
Proteinuria
 Drug: atorvastatin (Sortis) 40 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence of Adding Atorvastatin to Dual Renin-Angiotensin-Aldosterone System Blockade on Proteinuria

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Gdansk:

Primary Outcome Measures:
  • Investigate the antiproteinuric effect of adding atorvastatin to the combination therapy with angiotensin converting enzyme inhibitor and AT-1 receptor blocker in maximal recommended doses

Secondary Outcome Measures:
  • Investigate the effect of the study intervention on urine excretion of N-acetyl-β-D-glucosaminidase, alfa1-microglobulin and amino-terminal propeptide of type III procollagen.

Study Start Date: February 2005
Intervention Details:
    Drug: atorvastatin (Sortis) 40 mg
    In the 8-weeks run-in period angiotensin-converting enzyme inhibitors and angiotensin II type 1 receptor blockers were administered to achieve the target blood pressure below 130/80 mmHg. Next, they were randomly assigned to add (or not) 40 mg of atorvastatin in two active treatment periods lasting 8 weeks each
Detailed Description:

The renin-angiotensin-aldosterone system (RAAS) plays an important role in the progression of chronic kidney diseases (CKD), and inhibition of the RAAS with angiotensin-converting enzyme inhibitors (ACEI) and angiotensin II type 1 receptor blockers (ARB) may retard CKD progression. Dual pharmacological blockade of the RAAS with ACEI and ARB is recommended as a standard renoprotective management at least in patients with nondiabetic proteinuric CKD. However, neither ACEI nor ARB, even in high doses or in concomitant usage, abrogate the progression of CKD completely. Innovative approaches are needed to keep patients with CKD off dialysis. Additional statin (Atorvastatin) pathway may prove to be such beneficial therapeutic concept.Given these facts additional administration of statin to combination treatment with ACEI and ARB, may provide additional renal protection. To shed more light on this issue, we performed a randomised open controlled study to evaluate the influence of triple therapy with ACEI and/orARB and statin on surrogate markers of kidney injury, i.e. proteinuria, markers of tubular involvement and kidney fibrosis.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic kidney disease
  • Stable proteinuria above 300 mg/24 hours (no variations above 25% in the last 6 months)
  • Normal or slightly impaired stable renal function defined as serum creatinine level below 1.7 mg/dl (eGFR > 45 ml/min)

Exclusion Criteria:

  • Nephrotic syndrome
  • Steroids or other immunosuppressive treatment minimum during six months before the study
  • Diabetes mellitus
  • Potassium serum level > 5.1 mEq/L
  • Albumin serum level < 2.0mg/dL
  • Creatinine serum level >2 mg/dl
  • Current diagnosis of heart failure New York Heart Association (NYHA) Class II-IV
  • Clinically significant valvular heart disease or second or third degree heart block without a pacemaker
  • History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic cerebral attack
  • History of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention
  • History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years
  • Pregnant or nursing women
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.
  • History of alcohol abuse
  • NSAID abuse (more than 2 doses per week)
  • Known or suspected contraindications to the study medications, including history of allergy to ACE inhibitors, AT-1 receptor blockers and atorvastatin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572312

Sponsors and Collaborators
Medical University of Gdansk
Investigators
Principal Investigator: Boleslaw Rutkowski, MD PhD Department of Nephrology Transplantology and Internal Medicine. Medical University of Gdansk.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00572312     History of Changes
Other Study ID Numbers: ST-4/ATOR/01
Study First Received: December 12, 2007
Last Updated: December 12, 2007
Health Authority: Poland: Ministry of Health

Keywords provided by Medical University of Gdansk:
Proteinuria,
atorvastatin

Additional relevant MeSH terms:
Kidney Diseases
Proteinuria
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Renal Insufficiency
Angiotensin-Converting Enzyme Inhibitors
Atorvastatin
Angiotensin II Type 1 Receptor Blockers
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Therapeutic Uses
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 16, 2013