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Renal Hemodynamic Effects of the HMG-CoA Reductase Inhibitors in Normal Volunteers and in Patients With Chronic Renal Failure

Primary Purpose

Hyperlipidemia, Hypertension, Chronic Renal Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Simvastatin
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Patients with chronic renal failure:

  1. Age 18 or older
  2. Chronic renal failure secondary to Autosomal Dominant Polycystic Kidney Disease
  3. Serum creatinine ≥ 1.4 but ≤ 2.0 mg/dl
  4. Creatinine or iothalamate clearance between 35-70 ml/min per 1.73m2
  5. Stable renal function for the three preceding months
  6. Blood pressure needs to be adequately controlled (< 140/90 mm Hg), with or without the use of antihypertensive agents. However, ACE inhibitors or AT1 receptor blockers must not be initiated, or have their dose increased during the study period.

Patients with normal renal function:

  1. Age 18 or older
  2. Normal renal function and diagnosed with Autosomal Dominant Polycystic Kidney Disease
  3. Serum creatinine ≤ 1.4
  4. Creatinine or iothalamate clearance ≥70 ml/min per 1.73m2
  5. Renal function has to be stable for the three preceding months
  6. Blood pressure needs to be adequately controlled (< 140/90 mm Hg), with or without the use of antihypertensive agents. However, ACE inhibitors or AT1 receptor blockers must not be initiated, or have their dose increased during the study period.

Exclusion criteria include:

  1. Patients using corticosteroids, cytotoxic drugs (alkylating agents, chlorambucil, cyclophosphamide), CellCept, or cyclosporin A therapy
  2. Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab)
  3. Serum transaminase levels (AST, ALT) 2 times the upper limit of normal
  4. Clinically significant medical conditions
  5. Pregnant patients, patients who are breast-feeding, or women intending to conceive during the course of the study
  6. Presence or suspicion of active infection, recent serious infection or chronic/recurrent viral or bacterial infection
  7. Presence of concomitant renal artery stenosis.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Effect of short term HMG-CoA reductase treatment
    Differences between mean values for RPF, GFR and FF at baseline versus mean values obtained for these same parameters after 4 weeks of treatment will be analyzed using two-tailed Student's paired t-test. A similar analysis will be performed regarding patient's profiles for creatinine clearance, serum creatinine, urinary protein excretion and serum lipids. All results will be expressed as mean ± standard deviations. Differences will be considered significant at P <0.05.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 24, 2015
    Last Updated
    March 15, 2023
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02511418
    Brief Title
    Renal Hemodynamic Effects of the HMG-CoA Reductase Inhibitors in Normal Volunteers and in Patients With Chronic Renal Failure
    Official Title
    Renal Hemodynamic Effects of the HMG-CoA Reductase Inhibitors in Normal Volunteers and in Patients With Chronic Renal Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    5. Study Description

    Brief Summary
    This study was done to determine whether Simvastatin (a medication commonly used to treat patients with high cholesterol levels in the blood increases blood flow to the kidneys and improves renal function in normal volunteers and patients with impaired renal function secondary to polycystic kidney diseases.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperlipidemia, Hypertension, Chronic Renal Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Simvastatin
    Primary Outcome Measure Information:
    Title
    Effect of short term HMG-CoA reductase treatment
    Description
    Differences between mean values for RPF, GFR and FF at baseline versus mean values obtained for these same parameters after 4 weeks of treatment will be analyzed using two-tailed Student's paired t-test. A similar analysis will be performed regarding patient's profiles for creatinine clearance, serum creatinine, urinary protein excretion and serum lipids. All results will be expressed as mean ± standard deviations. Differences will be considered significant at P <0.05.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Patients with chronic renal failure: Age 18 or older Chronic renal failure secondary to Autosomal Dominant Polycystic Kidney Disease Serum creatinine ≥ 1.4 but ≤ 2.0 mg/dl Creatinine or iothalamate clearance between 35-70 ml/min per 1.73m2 Stable renal function for the three preceding months Blood pressure needs to be adequately controlled (< 140/90 mm Hg), with or without the use of antihypertensive agents. However, ACE inhibitors or AT1 receptor blockers must not be initiated, or have their dose increased during the study period. Patients with normal renal function: Age 18 or older Normal renal function and diagnosed with Autosomal Dominant Polycystic Kidney Disease Serum creatinine ≤ 1.4 Creatinine or iothalamate clearance ≥70 ml/min per 1.73m2 Renal function has to be stable for the three preceding months Blood pressure needs to be adequately controlled (< 140/90 mm Hg), with or without the use of antihypertensive agents. However, ACE inhibitors or AT1 receptor blockers must not be initiated, or have their dose increased during the study period. Exclusion criteria include: Patients using corticosteroids, cytotoxic drugs (alkylating agents, chlorambucil, cyclophosphamide), CellCept, or cyclosporin A therapy Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) Serum transaminase levels (AST, ALT) 2 times the upper limit of normal Clinically significant medical conditions Pregnant patients, patients who are breast-feeding, or women intending to conceive during the course of the study Presence or suspicion of active infection, recent serious infection or chronic/recurrent viral or bacterial infection Presence of concomitant renal artery stenosis.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26614268
    Citation
    Zand L, Torres VE, Larson TS, King BF, Sethi S, Bergstralh EJ, Angioi A, Fervenza FC. Renal hemodynamic effects of the HMG-CoA reductase inhibitors in autosomal dominant polycystic kidney disease. Nephrol Dial Transplant. 2016 Aug;31(8):1290-5. doi: 10.1093/ndt/gfv394. Epub 2015 Nov 27.
    Results Reference
    derived

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    Renal Hemodynamic Effects of the HMG-CoA Reductase Inhibitors in Normal Volunteers and in Patients With Chronic Renal Failure

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