- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01213498
The Effects of Atorvastatin on the Nitric Oxide-system in Patients With Non-diabetic Nephropathy (STAN)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects will be examined on two examination days. 4 days prior to each examination day subjects are treated with either atorvastatin or placebo. During treatment periods subject are given a standardized diet.
On the examination days subject are given L-NMMA(L-NG-monomethyl Arginine citrate), a NO inhibitor, 6 mg bolus infusion followed by continuous 4 mg/kg/hr infusion for 1 hour. Renal function, central hemodynamic and vasoactive hormones are evaluated prior, during and after L-NMMA infusion.
Renal function is measured by renal clearance of 51Chromium-EDTA and urinary sodium, potassium and albumin concentration. Urinary excretion of protein from NCC, NKCC and ENaC will be measured to evaluate channel activity in the nephron.
Central blood pressure, pulse wave analysis, and augmentation index are measured using SphygmoCor® from Atcor.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Holstebro, Denmark, 7500
- Medicinsk Forskning, Regionshospitalet Holstebro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women
- minimum 20 years
- Chronic Kidney disease
- Estimated GFR (eGFR) between 30 and 90 ml/min
Exclusion Criteria:
- Nephrotic Syndrome
- Diabetes mellitus
- Anamnestic or clinical signs of significant heart, lung, lever, kidney, thyroid and brain disease
- Neoplastic disease
- Alcohol abuse,
- Drug abuse
- Pregnancy or nursing
- Blood donation within a month before examination
- Hgb < 6,0
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Atorvastatin
|
Zarator, 80 mg pr.
day for 5 days
Other Names:
|
Placebo Comparator: Unikalk
|
1 tablet Unikalk pr day for 5. days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fractional excretion of sodium (FeNa)
Time Frame: 5 days treatment
|
Fractional excretion of urinary sodium before, during and after L-NMMA infusion
|
5 days treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Systolic blood pressure
Time Frame: 5 days
|
5 days
|
Plasma renin concentration
Time Frame: 5 days
|
5 days
|
Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC)
Time Frame: 5 days
|
5 days
|
Arterial stiffness (Pulse wave velocity)
Time Frame: 5 days
|
5 days
|
Diastolic blood pressure
Time Frame: 5 day
|
5 day
|
Augmentation Index
Time Frame: 5 days
|
5 days
|
Urinary albumin excretion
Time Frame: 5 days
|
5 days
|
plasma aldosterone concentration
Time Frame: 5 days
|
5 days
|
Urinary Aquaporin 2(u-AQP2) excretion
Time Frame: 5 days
|
5 days
|
atrial natriuretic peptide (ANP) concentration
Time Frame: 5 days
|
5 days
|
Brain natriuretic peptide concentration
Time Frame: 5 days
|
5 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EBP-FHC-2010-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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