Optimalization of Nephroprotection Using Atorvastatin (Sortis)

NCT00572312 | Completed

• 1 other identifier: ST-4/ATOR/01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Kidney Disease; Proteinuria

Keywords

Proteinuria,; atorvastatin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

atorvastatin (Sortis) 40 mg DRUG

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Gdansk: lead

Related Publications (1)

• Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.

  PMID: 38018702 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Proteinuria

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Boleslaw Rutkowski, MD PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 13, 2007
• Study Start: February 1, 2005
• Last Updated: December 13, 2007

Record last verified: 2007-12