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The Effects of Atorvastatin on the Nitric Oxide-system in Patients With Non-diabetic Nephropathy (STAN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01213498
First received: September 19, 2010
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. The purpose of this study is to investigate the effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular variables in patients witk chronic kidney disease.


Condition Intervention Phase
Nephropathy
Cardiovascular Diseases
 Drug: Atorvastatin
Drug: Unikalk
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Atorvastatin on the Nitric Oxide-system in Patients With Non-diabetic Nephropathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • Fractional excretion of sodium (FeNa) [ Time Frame: 5 days treatment ] [ Designated as safety issue: No ]
    Fractional excretion of urinary sodium before, during and after L-NMMA infusion


Secondary Outcome Measures:
  • Systolic blood pressure [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Plasma renin concentration [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Arterial stiffness (Pulse wave velocity) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Diastolic blood pressure [ Time Frame: 5 day ] [ Designated as safety issue: No ]
  • Augmentation Index [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Urinary albumin excretion [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • plasma aldosterone concentration [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Urinary Aquaporin 2(u-AQP2) excretion [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • atrial natriuretic peptide (ANP) concentration [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Brain natriuretic peptide concentration [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: May 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atorvastatin Drug: Atorvastatin
Zarator, 80 mg pr. day for 5 days
Other Name: Zarator
Placebo Comparator: Unikalk Drug: Unikalk
1 tablet Unikalk pr day for 5. days
Other Name: Unikalk

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213498

Locations
Denmark
Medicinsk Forskning, Regionshospitalet Holstebro
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
  More Information

No publications provided

Responsible Party: Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT01213498     History of Changes
Other Study ID Numbers: EBP-FHC-2010-2
Study First Received: September 19, 2010
Last Updated: January 27, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Regional Hospital Holstebro:
Nephrology
Atorvastatin
L-NMMA
NO

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Nitric Oxide
Atorvastatin
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on June 13, 2013