Chronic Kidney DiseasePhase 4NCT01541267
The Effect of Various Types of the Renin-angiotensin-aldosterone System Blockade on Proteinuria
A Phase 4 study testing aliskiren, eplerenon, telmisartan in people with Chronic Kidney Disease and Proteinuria, run by Medical University of Gdansk.
Trial summary
The main purpose of the study is to compare the effects of three different types of RAAS blockade on 24 hours proteinuria in patients with non-diabetic chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Disease, Proteinuria
- What is being tested?
- aliskiren, eplerenon, telmisartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Nov 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-65 years
- chronic non-diabetic proteinuric nephropathy
- chronic kidney disease stage 1-3
- stable proteinuria above 500 mg/24 hours
- blood pressure above 125/75 mmHg and below 150/95 mmHg
- no steroids or other immunosuppressive treatment for a minimum of six months before the study
Who cannot join
- unstable coronary heart disease
- decompensated congestive heart failure in the previous 6 months
- episode of malignant hypertension or stroke in the history
- diabetes
- creatinine clearance below 30 ml/min
- pregnancy
About this study
Official title: The Effect of Various Types of the Renin-angiotensin-aldosterone System Blockade on Proteinuria in Chronic Non-diabetic Kidney Disease: a Double-blind Cross-over Randomised Controlled Study
The main purpose of the study is to compare the effects of three different types of RAAS blockade on 24 hours proteinuria in patients with non-diabetic chronic kidney disease.
Read the detailed description
Pharmacological blockade of the renin-angiotensin-aldosterone system (RAAS) is the main target of therapy to reduces both proteinuria and the rate of decline of the glomerular filtration rate in non-diabetic chronic renal diseases. Despite recent progress, however, there is still no optimal therapy that can stop the progression of these nephropathies. Therefore, it is necessary to optimize such treatment for further improving renal outcome.
The aim of the present study was to compare the effects of three different types of RAAS blockade: (1) mineralocorticoid receptor blocker (MRB) + angiotensin receptor antagonist (ARA); (2) direct renin inhibitor (DRI) + ARA and (3) double maximal dose of ARA on 24 hours proteinuria in patients with non-diabetic chronic kidney disease
- Conditions
- Chronic Kidney Disease, Proteinuria
- Being tested
- aliskiren, eplerenon, telmisartan
- Keywords
- aliskiren, eplerenon, telmisartan, direct renin inhibitor, ACE inhibitor, mineralocorticoid inhibitor, proteinuria, chronic kidney diseases, renin-angiotensin-aldosterone system
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aliskiren, eplerenon, telmisartanDrug
aliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim)
| Study group | Role | What they receive |
|---|---|---|
| C - A - B | Active comparator | (A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg Receives: Drug: aliskiren, eplerenon, telmisartan |
| B - A - C | Active comparator | (A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg Receives: Drug: aliskiren, eplerenon, telmisartan |
| A - B - C | Active comparator | (A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg Receives: Drug: aliskiren, eplerenon, telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in urinary albumin-to-creatinine ratio (UACR) between treatment arms
changes of UACR
Measured: baseline and the end of 8 week treatments
Secondary outcomes (2)
Difference in transforming growth factor beta (TGF-beta) between treatment arms
Changes of urinary excretion of transforming growth factor beta (TGF-beta)
Measured: baseline and the end of 8 week treatments
Difference in serum potassium and creatinine between treatment arms
Measured: baseline and the end of 8 week treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startDec 2009
- Primary completionMay 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leszek Tylicki, Medical University of Gdansk
- Investigators
- Bolesław Rutkowski, Professor, Principal investigator, Departmen of Nephrology, Transplantation adn Internal Medicine, Medical University of Gdańsk, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541267
- Sponsor's protocol ID
- ST-4/Aliskiren/2011
- Status last verified
- Feb 2012
- First submitted
- 11 Feb 2012
- Last updated
- 29 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Various Types of the Renin-angiotensin-aldosterone System Blockade on Proteinuria in Chronic Non-diabetic Kidney Disease: a Double-blind Cross-over Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT01541267
- Acronym / sponsor ID
- ST-4/Aliskiren/2011
- Conditions
- Chronic Kidney Disease, Proteinuria
- Keywords
- aliskiren, eplerenon, telmisartan, direct renin inhibitor, ACE inhibitor, mineralocorticoid inhibitor, proteinuria, chronic kidney diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 29 Feb 2012 (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 main purpose of the study is to compare the effects of three different types of RAAS blockade on 24 hours proteinuria in patients with non-diabetic chronic kidney disease.
Detailed description
Pharmacological blockade of the renin-angiotensin-aldosterone system (RAAS) is the main target of therapy to reduces both proteinuria and the rate of decline of the glomerular filtration rate in non-diabetic chronic renal diseases. Despite recent progress, however, there is still no optimal therapy that can stop the progression of these nephropathies. Therefore, it is necessary to optimize such treatment for further improving renal outcome.
The aim of the present study was to compare the effects of three different types of RAAS blockade: (1) mineralocorticoid receptor blocker (MRB) + angiotensin receptor antagonist (ARA); (2) direct renin inhibitor (DRI) + ARA and (3) double maximal dose of ARA on 24 hours proteinuria in patients with non-diabetic chronic kidney disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| C - A - B | Active comparator | Drug: aliskiren, eplerenon, telmisartan(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg |
| B - A - C | Active comparator | Drug: aliskiren, eplerenon, telmisartan(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg |
| A - B - C | Active comparator | Drug: aliskiren, eplerenon, telmisartan(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18-65 years
- chronic non-diabetic proteinuric nephropathy
- chronic kidney disease stage 1-3
- stable proteinuria above 500 mg/24 hours
- blood pressure above 125/75 mmHg and below 150/95 mmHg
Key exclusion criteria (6 listed)
- unstable coronary heart disease
- decompensated congestive heart failure in the previous 6 months
- episode of malignant hypertension or stroke in the history
- diabetes
- creatinine clearance below 30 ml/min
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 |
|---|---|---|
| aliskiren, eplerenon, telmisartanaliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim) | Drug | A - B - C, B - A - C, C - A - B |
Primary outcome
Difference in urinary albumin-to-creatinine ratio (UACR) between treatment arms
Time frame: baseline and the end of 8 week treatments
changes of UACR
2 secondary outcomes
Difference in transforming growth factor beta (TGF-beta) between treatment arms
Time frame: baseline and the end of 8 week treatments
Difference in serum potassium and creatinine between treatment arms
Time frame: baseline and the end of 8 week treatments
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 29 Feb 2012.
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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.
Bolesław Rutkowski, Professor principal investigator
Departmen of Nephrology, Transplantation adn Internal Medicine, Medical University of Gdańsk, Poland
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aliskiren, eplerenon, telmisartan in people with Chronic Kidney Disease and Proteinuria, run by Medical University of Gdansk.
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 6 inclusion and 6 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 29 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Difference in urinary albumin-to-creatinine ratio (UACR) between treatment arms (time frame: baseline and the end of 8 week treatments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Feb 2012.