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

NCT ID: NCT01213498

Last Updated: 2015-08-21

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

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nephropathy Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Atorvastatin

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Zarator, 80 mg pr. day for 5 days

Unikalk

Group Type PLACEBO_COMPARATOR

Unikalk

Intervention Type DRUG

1 tablet Unikalk pr day for 5. days

Interventions

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Atorvastatin

Zarator, 80 mg pr. day for 5 days

Intervention Type DRUG

Unikalk

1 tablet Unikalk pr day for 5. days

Intervention Type DRUG

Other Intervention Names

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Zarator

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erling Bjerregaard Pedersen

OTHER

Sponsor Role lead

Responsible Party

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Erling Bjerregaard Pedersen

professor, chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Medicinsk Forskning, Regionshospitalet Holstebro

Holstebro, , Denmark

Site Status

Countries

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Denmark

References

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Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.

Reference Type DERIVED
PMID: 38018702 (View on PubMed)

Other Identifiers

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EBP-FHC-2010-2

Identifier Type: -

Identifier Source: org_study_id

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