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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02511418
• Other study ID #: 475-01
• Status: Completed
• Phase: N/A

Study information

• Verified date: March 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Renal Failure
• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Simvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks