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

Primary Purpose

Chronic Kidney Insufficiency, Hypertension, Vasodilation

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Beta-blocker, ACE-inhibitor
Calcium Channel Blockers, ACE-Inhibitor
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Insufficiency

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Renal Medicine, Aarhus University Hospital, Skejby

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard treatment

Intensive vasodilation

Arm Description

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

Patients with CKD 3-4 and hypertension, randomized to treatment with calcium channel blocker and if needed ACE-inhibitor or ARB for 18 months

Outcomes

Primary Outcome Measures

Change in glomerular filtration rate between the two treatment arms.

Secondary Outcome Measures

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.

Full Information

First Posted
June 20, 2011
Last Updated
February 26, 2014
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01380717
Brief Title
Renal and Systemic Vascular Resistance in Chronic Kidney Disease (CKD)
Acronym
RenVas
Official Title
The Role of Renal and Peripheral Vascular Resistance in Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Insufficiency, Hypertension, Vasodilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
Patients with CKD 3-4, hypertension, treated for 18 months with beta-blocker and if needed ACE-inhibitor or ARB.
Arm Title
Intensive vasodilation
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Beta-blocker, ACE-inhibitor
Intervention Description
Beta-blocker: 50- 100 mg 1-2 times a day. ACEi: 5-10 mg once a day
Intervention Type
Drug
Intervention Name(s)
Calcium Channel Blockers, ACE-Inhibitor
Intervention Description
Calcium Channel Blockers: 5-10 mg a day. ACEi: 5-10 mg a day
Primary Outcome Measure Information:
Title
Change in glomerular filtration rate between the two treatment arms.
Time Frame
Measured at baseline and after 18 months of treatment
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Henrik Buus, DrMedSc
Organizational Affiliation
Department og Renal Medicine, Aarhus University Hospital, Skejby
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Renal Medicine, Aarhus University Hospital, Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

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

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