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

NCT ID: NCT02511418

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperlipidemia Hypertension Chronic Renal Failure

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Simvastatin

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Fernando Fervenza

M.D., Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 26614268 (View on PubMed)

Other Identifiers

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475-01

Identifier Type: -

Identifier Source: org_study_id

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