Renal and Systemic Vascular Resistance in Chronic Kidney Disease (CKD) (RenVas)

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

University of Aarhus

ClinicalTrials.gov Identifier:

NCT01380717

First received: June 20, 2011

Last updated: September 21, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 20, 2011

Last Updated Date

September 21, 2012

Start Date ^ICMJE

February 2011

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in glomerular filtration rate between the two treatment arms. [ Time Frame: Measured at baseline and after 18 months of treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01380717 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes in glomerular filtration rate stratified after changes in pulse wave velocity, renal vascular resistance and forearm minimal resistance at baseline and after 18 months of treatment. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Renal and Systemic Vascular Resistance in Chronic Kidney Disease (CKD)

Official Title ^ICMJE

The Role of Renal and Peripheral Vascular Resistance in Chronic Kidney Disease

Brief Summary

Patients with reduced kidney function have a higher risk of heart disease and death. Studies have shown that blood vessels in patients with hypertension change with a decrease of lumen size and growth of the vessel wall. By treating patients with antihypertensive certain medication vessel lumen and walls normalize. Treating hypertension in patients with chronic kidney disease slows the progression of kidney function loss.

The aim is to compare different degrees of antihypertensive medication in patients with chronic kidney disease and hypertension will slow the progression of kidney loss.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Kidney Insufficiency
Hypertension
Vasodilation

Intervention ^ICMJE

Drug: Beta-blocker, ACE-inhibitor
Beta-blocker: 50- 100 mg 1-2 times a day. ACEi: 5-10 mg once a day
Drug: Calcium Channel Blockers, ACE-Inhibitor
Calcium Channel Blockers: 5-10 mg a day. ACEi: 5-10 mg a day

Study Arm (s)

Active Comparator: Standard treatment
Patients with CKD 3-4, hypertension, treated for 18 months with beta-blocker and if needed ACE-inhibitor or ARB.

Intervention: Drug: Beta-blocker, ACE-inhibitor
Active Comparator: Intensive vasodilation
Patients with CKD 3-4 and hypertension, randomized to treatment with calcium channel blocker and if needed ACE-inhibitor or ARB for 18 months

Intervention: Drug: Calcium Channel Blockers, ACE-Inhibitor

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

eGFR 15-60 ml/min for at least 3 months
Blood pressure > 130 mmHg systolic og >80 mmHg diastolic (patients without antihypertensive treatment or in treatment with Beta-blockers, ACEi, ARBs or CCB not in maximum dosi).
Blood pressure < 130 mmHg systolic og < 80 mmHg diastolic (patients receiving Beta-blockers, ACEi, ARBs og CCB).
Fertile women using safe contraceptives

Exclusion Criteria:

Ultrasound verified Polycystic Kidney Disease (ADPKD)
Claustrophobia (MRi scan).
Contraindications to MRi.
Pregnancy or wish to become pregnant in the study period.
Nephrotic syndrome with gross edema.
Known allergy to any study medication.
Blood pressure < 130 mmHg systolic or < 80 mmHg diastolic without antihypertensive treatment.
Blood pressure > 130 mmHg systolic or > 80 mmHg diastolic and in maximum dosages of all three Beta-blockers, ACEi (ARBs) and CCB.

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01380717

Other Study ID Numbers ^ICMJE

RenVas

Has Data Monitoring Committee

Yes

Responsible Party

University of Aarhus

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Niels Henrik Buus, DrMedSc

Department og Renal Medicine, Aarhus University Hospital, Skejby

Information Provided By

University of Aarhus

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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