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
About this trial
This is an interventional treatment trial for Chronic Kidney Insufficiency
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.
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
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
Learn more about this trial
Renal and Systemic Vascular Resistance in Chronic Kidney Disease (CKD)
We'll reach out to this number within 24 hrs