The Effects of Atorvastatin on the Nitric Oxide-system in Patients With Non-diabetic Nephropathy (STAN)
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|ClinicalTrials.gov Identifier: NCT01213498|
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : August 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Nephropathy Cardiovascular Diseases||Drug: Atorvastatin Drug: Unikalk||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Effects of Atorvastatin on the Nitric Oxide-system in Patients With Non-diabetic Nephropathy|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
|Active Comparator: Atorvastatin||
Zarator, 80 mg pr. day for 5 days
Other Name: Zarator
|Placebo Comparator: Unikalk||
1 tablet Unikalk pr day for 5. days
- Fractional excretion of sodium (FeNa) [ Time Frame: 5 days treatment ]Fractional excretion of urinary sodium before, during and after L-NMMA infusion
- Systolic blood pressure [ Time Frame: 5 days ]
- Plasma renin concentration [ Time Frame: 5 days ]
- Arterial stiffness (Pulse wave velocity) [ Time Frame: 5 days ]
- Diastolic blood pressure [ Time Frame: 5 day ]
- Augmentation Index [ Time Frame: 5 days ]
- Urinary albumin excretion [ Time Frame: 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 ]
- plasma aldosterone concentration [ Time Frame: 5 days ]
- Urinary Aquaporin 2(u-AQP2) excretion [ Time Frame: 5 days ]
- atrial natriuretic peptide (ANP) concentration [ Time Frame: 5 days ]
- Brain natriuretic peptide concentration [ Time Frame: 5 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213498
|Medicinsk Forskning, Regionshospitalet Holstebro|
|Holstebro, Denmark, 7500|