Kidney Failure, ChronicPhase 4NCT00235287
Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease
A Phase 4 study testing Candesartan and enalapril in people with Kidney Failure, Chronic and Cardiovascular Diseases, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether a combination therapy with angiotensin-converting enzyme (ACE)-inhibitors and angiotensin receptor blockers reduces the arterial stiffness assessed by applantiontonometry more than a single treatment in kidney patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Failure, Chronic, Cardiovascular Diseases
- What is being tested?
- Candesartan and enalapril
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2005to not given
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Creatinine: 150-350 micromol/L
- Blood pressure > 110 systolic
- Negative pregnancy test for fertile women
- Written and oral informed consent from the patient
Who cannot join
- Treatment with both ACE-inhibitors (ACE-I) and angiotensin receptor blockers
- Pregnancy or breastfeeding
- Treatment with immunosuppressive medication, steroids or non-steroidal anti-inflammatory drugs (NSAIDs)
- Serious chronic heart failure (New York Heart Association [NYHA] III-IV)
- Chronic liver disease
- Suspicion or verified kidney artery stenosis
Show all 15Show fewer
- Cardiac arrhythmia and/or implanted pacemaker
- Myocardial infarction or cerebrovascular incidence within the last 3 months
- Allergy towards ACE-I or angiotensin receptor blockers
- Amputation of a whole extremity or the crural or femoral part of the leg
- Dementia or a psychological condition that makes understanding of the examination conditions impossible
- Dialysis or renal transplantation
- Treatment with aldosterone antagonists
- Hyperkalemia > 5.5 mmol/l
- Another serious chronic non-renal disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Dept. of Nephrology, Herlev University Hospital
Herlev, 2730
Marie Frimodt-Møller, MD, + 45 44 88 44 88 ext. 84878, marfri01@heh.regionh.dk
Arne H Nielsen, MD, Prof., + 45 44 88 44 88 ext. 82277, arhn@heh.regionh.dk
About this study
Official title: Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease: An Interventional and Methodological Study
The purpose of this study is to determine whether a combination therapy with angiotensin-converting enzyme (ACE)-inhibitors and angiotensin receptor blockers reduces the arterial stiffness assessed by applantiontonometry more than a single treatment in kidney patients.
- Conditions
- Kidney Failure, Chronic, Cardiovascular Diseases
- Being tested
- Candesartan and enalapril
- Keywords
- Angiotensin-Converting Enzyme Inhibitors, type 1 angiotensin receptor antagonists, blood pressure
- Medical subject headings
- Kidney Failure, Chronic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candesartan and enalaprilDrug
24 weeks of treatment with Candesartan in incremental doses (4,8,16 mg), where Enalapril is added in incremental doses (5,10 and 20 mg)the last 8 weeks.
candesartan and enalaprilDrug
24 weeks of treatment with Enalapril in incremental doses (5, 10, 20 mg), where Candesartan is added in incremental doses (4,8,16 mg) in the last 8 weeks.
candesartan and enalaprilDrug
8 weeks of treatment with Candesartan in incremental doses (4,8,16 mg), followed by 8 weeks of treatment with Enalapril in incremental doses (/5,10,20 mg). The treatment in the last 8 out of the 24 weeks is a combination of Candesartan in incremental doses (4,8,16 mg) and Enalapril 20 mg.
candesartan and enalaprilDrug
8 weeks of treatment with Enalapril in incremental doses (5,10,20 mg), followed by 8 weeks of treatment with Candesartan (4,8,16 mg). The treatment in the last 8 out of the 24 weeks is a combination of Candesartan 16 mg and Enalapril in incremental doses (5,10,20 mg)
| Study group | Role | What they receive |
|---|---|---|
| A,AIIA | Active comparator | 24 weeks of treatment with Candesartan, where Enalapril is added in the last 8 weeks. Receives: Drug: Candesartan and enalapril |
| A, ACE-I | Active comparator | 24 weeks of treatment with Enalapril, where Candesartan is added in the last 8 weeks. Receives: Drug: candesartan and enalapril |
| C, AIIA | Active comparator | 8 weeks of treatment with Candesartan, followed by 8 weeks of treatment with Enalapril. The treatment in the last 8 out of the 24 weeks is a combination of Candesartan and Enalapril. Receives: Drug: candesartan and enalapril |
| C, ACE | Active comparator | 8 weeks of treatment with Enalapril in incremental doses (5,10,20 mg) , followed by 8 weeks of treatment with Candesartan in incremental doses (4,8,16 mg) . The treatment in the last 8 out of the 24 weeks is a combination of Candesartan 16 mg and Enalapril in incremental doses (5,10,20 mg) Receives: Drug: candesartan and enalapril |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulse wave velocity (aortic and brachial)
Measured: 0, 8, 16 and 24 weeks after start of intervention
Secondary outcomes (7)
augmentation index
Measured: 0, 8, 16 and 24 weeks after start of intervention
blood pressure (brachial and aortic)
Measured: 0, 8, 16 and 24 weeks after start of intervention
buckbergs index
Measured: 0, 8, 16 and 24 weeks after start of interven
time to reflection
Measured: 0, 8, 16 and 24 weeks after start of interven
pulse pressure
Measured: 0, 8, 16 and 24 weeks after start of interven
change in glomerular filtration rate (GFR)
Measured: 0, 8, 16 and 24 weeks after start of interven
blood parameters
Measured: at start of intervention and after each 2.5 - 3.week in the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Marie Frimodt-Møller, MD, Principal investigator, Dept. of Nephrology, Herlev University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235287
- Sponsor's protocol ID
- RAS-block study
- Status last verified
- Jan 2009
- First submitted
- 6 Oct 2005
- Last updated
- 19 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cooper TE, Teng C, Tunnicliffe DJ, Cashmore BA, Strippoli GF. Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers for adults with early (stage 1 to 3) non-diabetic chronic kidney disease. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD007751. doi: 10.1002/14651858.CD007751.pub3.
PubMed 37466151Frimodt-Moller M, Kamper AL, Strandgaard S, Kreiner S, Nielsen AH. Beneficial effects on arterial stiffness and pulse-wave reflection of combined enalapril and candesartan in chronic kidney disease--a randomized trial. PLoS One. 2012;7(7):e41757. doi: 10.1371/journal.pone.0041757. Epub 2012 Jul 31.
PubMed 22860014
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease: An Interventional and Methodological Study
- ClinicalTrials.gov ID
- NCT00235287
- Acronym / sponsor ID
- RAS-block study
- Conditions
- Kidney Failure, Chronic, Cardiovascular Diseases
- Keywords
- Angiotensin-Converting Enzyme Inhibitors, type 1 angiotensin receptor antagonists, blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Sep 2005
- First posted
- 10 Oct 2005 (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.
The purpose of this study is to determine whether a combination therapy with angiotensin-converting enzyme (ACE)-inhibitors and angiotensin receptor blockers reduces the arterial stiffness assessed by applantiontonometry more than a single treatment in kidney patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A,AIIA | Active comparator | Drug: Candesartan and enalapril24 weeks of treatment with Candesartan, where Enalapril is added in the last 8 weeks. |
| A, ACE-I | Active comparator | Drug: candesartan and enalapril24 weeks of treatment with Enalapril, where Candesartan is added in the last 8 weeks. |
| C, AIIA | Active comparator | Drug: candesartan and enalapril8 weeks of treatment with Candesartan, followed by 8 weeks of treatment with Enalapril. The treatment in the last 8 out of the 24 weeks is a combination of Candesartan and Enalapril. |
| C, ACE | Active comparator | Drug: candesartan and enalapril8 weeks of treatment with Enalapril in incremental doses (5,10,20 mg) , followed by 8 weeks of treatment with Candesartan in incremental doses (4,8,16 mg) . The treatment in the last 8 out of the 24 weeks is a combination of Candesartan 16 mg and Enalapril in incremental doses (5,10,20 mg) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Creatinine: 150-350 micromol/L
- Blood pressure > 110 systolic
- Negative pregnancy test for fertile women
- Written and oral informed consent from the patient
Key exclusion criteria (15 listed)
- Treatment with both ACE-inhibitors (ACE-I) and angiotensin receptor blockers
- Pregnancy or breastfeeding
- Treatment with immunosuppressive medication, steroids or non-steroidal anti-inflammatory drugs (NSAIDs)
- Serious chronic heart failure (New York Heart Association [NYHA] III-IV)
- Chronic liver disease
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 |
|---|---|---|
| Candesartan and enalapril24 weeks of treatment with Candesartan in incremental doses (4,8,16 mg), where Enalapril is added in incremental doses (5,10 and 20 mg)the last 8 weeks. | Drug | A,AIIA |
| candesartan and enalapril24 weeks of treatment with Enalapril in incremental doses (5, 10, 20 mg), where Candesartan is added in incremental doses (4,8,16 mg) in the last 8 weeks. | Drug | A, ACE-I |
| candesartan and enalapril8 weeks of treatment with Candesartan in incremental doses (4,8,16 mg), followed by 8 weeks of treatment with Enalapril in incremental doses (/5,10,20 mg). The treatment in the last 8 out of the 24 weeks is a combination of Candesartan in incremental doses (4,8,16 mg) and Enalapril 20 mg. | Drug | C, AIIA |
| candesartan and enalapril8 weeks of treatment with Enalapril in incremental doses (5,10,20 mg), followed by 8 weeks of treatment with Candesartan (4,8,16 mg). The treatment in the last 8 out of the 24 weeks is a combination of Candesartan 16 mg and Enalapril in incremental doses (5,10,20 mg) | Drug | C, ACE |
Primary outcome
pulse wave velocity (aortic and brachial)
Time frame: 0, 8, 16 and 24 weeks after start of intervention
7 secondary outcomes
augmentation index
Time frame: 0, 8, 16 and 24 weeks after start of intervention
blood pressure (brachial and aortic)
Time frame: 0, 8, 16 and 24 weeks after start of intervention
buckbergs index
Time frame: 0, 8, 16 and 24 weeks after start of interven
time to reflection
Time frame: 0, 8, 16 and 24 weeks after start of interven
pulse pressure
Time frame: 0, 8, 16 and 24 weeks after start of interven
change in glomerular filtration rate (GFR)
Time frame: 0, 8, 16 and 24 weeks after start of interven
blood parameters
Time frame: at start of intervention and after each 2.5 - 3.week in the study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2009.
- Derived from this study: PubMed 37466151Cooper TE, Teng C, Tunnicliffe DJ, Cashmore BA, Strippoli GF. Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers for adults with early (stage 1 to 3) non-diabetic chronic kidney disease. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD007751. doi: 10.1002/14651858.CD007751.pub3.
- Derived from this study: PubMed 22860014Frimodt-Moller M, Kamper AL, Strandgaard S, Kreiner S, Nielsen AH. Beneficial effects on arterial stiffness and pulse-wave reflection of combined enalapril and candesartan in chronic kidney disease--a randomized trial. PLoS One. 2012;7(7):e41757. doi: 10.1371/journal.pone.0041757. Epub 2012 Jul 31.
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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.
Marie Frimodt-Møller, MD principal investigator
Dept. of Nephrology, Herlev University Hospital
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 Candesartan and enalapril in people with Kidney Failure, Chronic and Cardiovascular Diseases, run by Herlev Hospital 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 15 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: status not confirmed, as of the sponsor's last update on 19 Jan 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Frimodt-Møller, MD (+ 45 44 88 44 88 ext. 84878, marfri01@heh.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulse wave velocity (aortic and brachial) (time frame: 0, 8, 16 and 24 weeks after start of intervention). 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 NCT00235287, which also lists 2 linked publications.
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 19 Jan 2009.