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Optimalization of Nephroprotection Using Atorvastatin (Sortis)

Primary Purpose

Chronic Kidney Disease, Proteinuria

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

atorvastatin (Sortis) 40 mg

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Proteinuria,, atorvastatin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

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.

Full Information

NCT ID

NCT00572312

First Posted

December 12, 2007

Last Updated

December 12, 2007

Sponsor

Medical University of Gdansk

1. Study Identification

Unique Protocol Identification Number

NCT00572312

Brief Title

Optimalization of Nephroprotection Using Atorvastatin (Sortis)

Official Title

Influence of Adding Atorvastatin to Dual Renin-Angiotensin-Aldosterone System Blockade on Proteinuria

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

February 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Gdansk

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease, Proteinuria

Keywords

Proteinuria,, atorvastatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

atorvastatin (Sortis) 40 mg

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boleslaw Rutkowski, MD PhD

Organizational Affiliation

Department of Nephrology Transplantology and Internal Medicine. Medical University of Gdansk.

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Optimalization of Nephroprotection Using Atorvastatin (Sortis)

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