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Completed

NCT Number: NCT00768638

Study of Atorvastatin Dose Dependent Reduction of Proteinuria

Randomized controlled double blind study of parallel groups to evaluate the comparative effects of low-dose of atorvastatin on proteinuria in patients with stage 3 or 4 chronic kidney disease.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôtel-Dieu de Québec Hospital

Québec, Quebec, G1R2J6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age of 18 and over
  • Stage 3 or 4 chronic kidney disease (modified MDRD)
  • proteinuria of > 1g/d on ACEi and/or ARB, or proteinuria of > 1g/d with intolerance or contraindication to ACEi and/or ARB
  • blood pressure < 130/80 mmHg or < 140/90 mmHg in patients with five or more antihypertensive drugs
  • stable renal function

Exclusion criteria

  • rapid progression of renal failure
  • immunosuppressive therapy within the past 3 months
  • need a renal replacement therapy within 8 months
  • definite history of chronic liver disease, or abnormal liver function
  • evidence of active inflammatory muscle disease
  • definite previous adverse reaction to a statin
  • concurrent treatment with a contraindicated drug (fibrate, macrolide antibiotic, systemic use of imidazole or triazole antifungals, protease-inhibitors, ciclosporin)
  • child bearing potential
  • known to be poorly compliant with clinic visits or prescribed medication

Treatment and study plan

atorvastatin

Drug

Atorvastatin 10mg 1co id (10mg active) Placebo 40mg 1co id (40mg inactive)

Other names: lipitor 10mg

Primary outcomes

  1. proteinuria

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

The Renal Protective Effects of Low-dose and High-dose Atorvastatin in Patients With Glomerular Disease and Proteinuria: a Randomized Controlled Double Blinded Study

Acronym: SARP

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Oct 8, 2008
Registry last updated
Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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