Kidney Failure, ChronicPhase 4NCT00430924
Inhibition of Aldosterone in Patients With Chronic Renal Disease
A Phase 4 study testing Eplerenone in people with Kidney Failure, Chronic, run by Lene Boesby at 2 sites in Denmark.
Trial summary
The purpose of this study is to examine whether the inhibition of aldosterone will result in lower excretion of protein via urine. The hypothesis is that if loss of protein is lowered, progression of renal disease with be slower than otherwise expected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Eplerenone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2007to Aug 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Proteinuria > 500 mg/24 hours
- Hypertension or anti-hypertensive treatment
Who cannot join
- Diabetic nephropathy
- GFR< 20 ml/min
- P-potassium between 3,5 mmol/l and 5,0 mmol/l
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Rigshospitalet, Blegdamsvej 9
Copenhagen, DK-2100 Ø
Herlev Hospital
Herlev, DK-2730
About this study
Official title: The Effect of Aldosterone Inhibition on Proteinuria in Patients With Progressive Renal Disease
The purpose of this study is to examine whether the inhibition of aldosterone will result in lower excretion of protein via urine. The hypothesis is that if loss of protein is lowered, progression of renal disease with be slower than otherwise expected.
Read the detailed description
Patients with chronic renal disease are likely to progress to end stage renal disease with the need for renal replacement therapy. It is accepted that proteinuria is a surrogate measurement for progression. If proteinuria can be lowered we hope to prolong patients pre-dialysis phase. Our theory is that aldosterone inhibition will lead to this.
For a period of 8 weeks patients will be randomized to either aldosterone receptor inhibition with the drug eplerenone or control without. Blood pressures will be kept at the same level using other drugs.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Eplerenone
- Keywords
- Kidney Failure, Chronic, Proteinuria, Aldosterone, Renin-Angiotensin System
- Medical subject headings
- Kidney Failure, Chronic, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
Once daily administration for 8 weeks and 8 weeks control.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Eplerenone Receives: Drug: Eplerenone |
| 2 | No intervention | Control Receives: Drug: Eplerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteinuria reduction
Measured: bi-monthly
Secondary outcomes (1)
Evaluating blood pressure response and hyperkalaemia after aldosterone inhibition.
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionAug 2009
- Study completionAug 2009
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lene Boesby
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Lene Boesby, Herlev Hospital
- Investigators
- Svend Strandgaard, DMSc, Study directorAnne-Lise Kamper, DMSc, Study director, nonaffiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430924
- Sponsor's protocol ID
- B109LB1
- Other IDs
- 2006-004411-21
- Status last verified
- Feb 2012
- First submitted
- 1 Feb 2007
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
PubMed 33107592Boesby L, Elung-Jensen T, Klausen TW, Strandgaard S, Kamper AL. Moderate antiproteinuric effect of add-on aldosterone blockade with eplerenone in non-diabetic chronic kidney disease. A randomized cross-over study. PLoS One. 2011;6(11):e26904. doi: 10.1371/journal.pone.0026904. Epub 2011 Nov 4.
PubMed 22073219
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aldosterone Inhibition on Proteinuria in Patients With Progressive Renal Disease
- ClinicalTrials.gov ID
- NCT00430924
- Acronym / sponsor ID
- B109LB1
- Conditions
- Kidney Failure, Chronic
- Keywords
- Kidney Failure, Chronic, Proteinuria, Aldosterone, Renin-Angiotensin System
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Lene BoesbyUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Mar 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 Feb 2007 (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 examine whether the inhibition of aldosterone will result in lower excretion of protein via urine. The hypothesis is that if loss of protein is lowered, progression of renal disease with be slower than otherwise expected.
Detailed description
Patients with chronic renal disease are likely to progress to end stage renal disease with the need for renal replacement therapy. It is accepted that proteinuria is a surrogate measurement for progression. If proteinuria can be lowered we hope to prolong patients pre-dialysis phase. Our theory is that aldosterone inhibition will lead to this.
For a period of 8 weeks patients will be randomized to either aldosterone receptor inhibition with the drug eplerenone or control without. Blood pressures will be kept at the same level using other drugs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: EplerenoneEplerenone |
| 2 | No intervention | Drug: EplerenoneControl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Proteinuria > 500 mg/24 hours
- Hypertension or anti-hypertensive treatment
Key exclusion criteria (3 listed)
- Diabetic nephropathy
- GFR< 20 ml/min
- P-potassium between 3,5 mmol/l and 5,0 mmol/l
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 |
|---|---|---|
| EplerenoneOnce daily administration for 8 weeks and 8 weeks control. | Drug | 1, 2 |
Primary outcome
Proteinuria reduction
Time frame: bi-monthly
1 secondary outcome
Evaluating blood pressure response and hyperkalaemia after aldosterone inhibition.
Time frame: weekly
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 8 Feb 2012.
- Derived from this study: PubMed 33107592Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
- Derived from this study: PubMed 22073219Boesby L, Elung-Jensen T, Klausen TW, Strandgaard S, Kamper AL. Moderate antiproteinuric effect of add-on aldosterone blockade with eplerenone in non-diabetic chronic kidney disease. A randomized cross-over study. PLoS One. 2011;6(11):e26904. doi: 10.1371/journal.pone.0026904. Epub 2011 Nov 4.
- PublicationLink provided by the sponsor.
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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.
Svend Strandgaard, DMSc study director
Anne-Lise Kamper, DMSc study director
nonaffiliated
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eplerenone in people with Kidney Failure, Chronic, run by Lene Boesby at 2 sites 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 2 inclusion and 3 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 8 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Proteinuria reduction (time frame: bi-monthly). 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 NCT00430924, 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 8 Feb 2012.