Chronic Kidney InsufficiencyPhase 4RenVasNCT01380717
Renal and Systemic Vascular Resistance in Chronic Kidney Disease (CKD)
A Phase 4 study testing Beta-blocker, ACE-inhibitor and Calcium Channel Blockers, ACE-Inhibitor in people with Chronic Kidney Insufficiency and Hypertension, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Insufficiency, Hypertension, Vasodilation
- What is being tested?
- Beta-blocker, ACE-inhibitor and Calcium Channel Blockers, ACE-Inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Feb 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Renal Medicine, Aarhus University Hospital, Skejby
Aarhus N, 8200
About this study
Official title: The Role of Renal and Peripheral Vascular Resistance in Chronic Kidney Disease
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.
- Conditions
- Chronic Kidney Insufficiency, Hypertension, Vasodilation
- Being tested
- Beta-blocker, ACE-inhibitor, Calcium Channel Blockers, ACE-Inhibitor
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-blocker, ACE-inhibitorDrug
Beta-blocker: 50- 100 mg 1-2 times a day. ACEi: 5-10 mg once a day
Calcium Channel Blockers, ACE-InhibitorDrug
Calcium Channel Blockers: 5-10 mg a day. ACEi: 5-10 mg a day
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Active comparator | Patients with CKD 3-4, hypertension, treated for 18 months with beta-blocker and if needed ACE-inhibitor or ARB. Receives: Drug: Beta-blocker, ACE-inhibitor |
| Intensive vasodilation | Active comparator | Patients with CKD 3-4 and hypertension, randomized to treatment with calcium channel blocker and if needed ACE-inhibitor or ARB for 18 months Receives: Drug: Calcium Channel Blockers, ACE-Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glomerular filtration rate between the two treatment arms.
Measured: Measured at baseline and after 18 months of treatment
Secondary outcomes (1)
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney InsufficiencyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niels Henrik Buus, DrMedSc, Principal investigator, Department og Renal Medicine, Aarhus University Hospital, Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380717
- Sponsor's protocol ID
- RenVas
- Acronym
- RenVas
- Status last verified
- Sep 2012
- First submitted
- 20 Jun 2011
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Svendsen SL, Rousing AQ, Carlsen RK, Khatir D, Jensen D, Hansen NM, Salomo L, Birn H, Buus NH, Leipziger J, Sorensen MV, Berg P. A Urine pH-Ammonium Acid/Base Score and CKD Progression. J Am Soc Nephrol. 2024 Nov 1;35(11):1533-1545. doi: 10.1681/ASN.0000000000000447. Epub 2024 Jul 17.
PubMed 39485702
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Renal and Peripheral Vascular Resistance in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01380717
- Acronym / sponsor ID
- RenVas / RenVas
- Conditions
- Chronic Kidney Insufficiency, Hypertension, Vasodilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Drug: Beta-blocker, ACE-inhibitorPatients with CKD 3-4, hypertension, treated for 18 months with beta-blocker and if needed ACE-inhibitor or ARB. |
| Intensive vasodilation | Active comparator | Drug: Calcium Channel Blockers, ACE-InhibitorPatients with CKD 3-4 and hypertension, randomized to treatment with calcium channel blocker and if needed ACE-inhibitor or ARB for 18 months |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-blocker, ACE-inhibitorBeta-blocker: 50- 100 mg 1-2 times a day. ACEi: 5-10 mg once a day | Drug | Standard treatment |
| Calcium Channel Blockers, ACE-InhibitorCalcium Channel Blockers: 5-10 mg a day. ACEi: 5-10 mg a day | Drug | Intensive vasodilation |
Primary outcome
Change in glomerular filtration rate between the two treatment arms.
Time frame: Measured at baseline and after 18 months of treatment
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
- Derived from this study: PubMed 39485702Svendsen SL, Rousing AQ, Carlsen RK, Khatir D, Jensen D, Hansen NM, Salomo L, Birn H, Buus NH, Leipziger J, Sorensen MV, Berg P. A Urine pH-Ammonium Acid/Base Score and CKD Progression. J Am Soc Nephrol. 2024 Nov 1;35(11):1533-1545. doi: 10.1681/ASN.0000000000000447. Epub 2024 Jul 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Henrik Buus, DrMedSc principal investigator
Department og Renal Medicine, Aarhus University Hospital, Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beta-blocker, ACE-inhibitor and Calcium Channel Blockers, ACE-Inhibitor in people with Chronic Kidney Insufficiency and Hypertension, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glomerular filtration rate between the two treatment arms. (time frame: Measured at baseline and after 18 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01380717, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2014.