End Stage Renal Disease / HemodialysisPhase 2MiREnDaNCT01691053
Mineralocorticoid Receptor Antagonists in End Stage Renal Disease
A Phase 2 study testing Spironolactone in people with End Stage Renal Disease / Hemodialysis, run by Wuerzburg University Hospital at 3 sites in Germany.
Trial summary
End stage renal disease (ESRD) patients exhibit an extraordinarily high annual mortality. Cardiovascular (CV) causes account for almost half of all-cause mortality. Increased left ventricular mass (LVM) is a common finding in ESRD patients on dialysis and is an independent predictor of survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease / Hemodialysis
- What is being tested?
- Spironolactone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 3 sitesGermany
- Study dates
- Dec 2012to 28 Mar 2018
- Phase
- Phase 2
- 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
- Age >18 years
- Hemodialysis treatment for at least 3 months
- At least 3 dialysis sessions per week
- Written informed consent
Who cannot join
- Contraindications for cardiac magnet resonance imaging (CMR)
- Mineralocorticoid receptor antagonist treatment within the last 6 months
- Estimated life expectancy < 12 months as judged by the nephrologist
- History of hyperkalemia, defined as pre-dialysis potassium > 6.5 mmol/l occurring ≥ 3 times within the last 3 months prior to enrolment.
- High risk to develop hyperkalemia defined as pre-dialysis potassium > 6.0 mmol/l
- Hypotension (systolic blood pressure < 100 mmHg)
Show all 11Show fewer
- Planned kidney transplantation (living donor) within the prospected study duration
- Any acute illness within the last 4 weeks precluding a study participation as judged by the nephrologist
- Non-amenorrheic women with child bearing potential without reliable contraception, pregnancy/lactation
- Allergy/hypersensitivity to spironolactone
- Non-compliance suspected or demonstrated
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University Hospital Erlangen-Nürnberg
Erlangen, 91054
University Hospital Frankfurt
Frankfurt, 60590
University Hospital Wuerzburg
Würzburg, 97080
About this study
Official title: Phase II Trial to Evaluate the Efficacy and Safety of Spironolactone in Hemodialysis Patients
End stage renal disease (ESRD) patients exhibit an extraordinarily high annual mortality. Cardiovascular (CV) causes account for almost half of all-cause mortality. Increased left ventricular mass (LVM) is a common finding in ESRD patients on dialysis and is an independent predictor of survival. Yet, to date there is no established medical treatment to reduce CV morbidity and mortality in ESRD patients on hemodialysis. Blockade of aldosterone action by means of mineralocorticoid receptor antagonists (MRA) provides cardioprotection and improves outcome in heart failure patients. Furthermore, the MRA spironolactone has recently been shown to reduce LVM in patients with mild-to-moderate chronic kidney disease (CKD). The investigators here hypothesize that spironolactone treatment is cardioprotective by reducing LVM in ESRD patients on dialysis.
- Conditions
- End Stage Renal Disease / Hemodialysis
- Being tested
- Spironolactone, Placebo
- Keywords
- End stage renal disease, Hemodialysis, Spironolactone, Left ventricular hypertrophy
- Medical subject headings
- Kidney Failure, Chronic, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
50mg once daily
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Spironolactone | Active comparator | Not described Receives: Drug: Spironolactone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Mass Index
as assessed by cardiac MRI
Measured: 9 months
Secondary outcomes (9)
Cardiac function parameters
cardiac volumes, systolic and diastolic function, cardiac output as measured by cardiac MRI and echocardiography
Measured: 9 months
Office and 24h blood pressure
Measured: 9 months
Clinical measures of heart failure severity
New York Heart Association (NYHA) functional class, 6 minute walk test
Measured: 9 months
Vascular function
Carotid intima meda thickness, pulse wave analysis, carotid artery distensibility, flow mediated dilatation of the brachial artery
Measured: 9 months
Biomarkers of heart failure, inflammation and fibrosis
Measured: 9 months
Quality of Life - Hospital Anxiety and Depression Scale (HADS)
Quality of life will be measured by analyzing HADS
Measured: 9 months
Cardiac death and/or hospitalization for heart failure
Measured: 9 months
Safety measures
Pre-dialysis potassium levels, frequency of hyperkalemic episodes (K>6.5mmol/l), measurement of residual kidney function (if applicable)
Measured: 9 months
Quality of Life - Kidney Disease Quality of Life Instrument (KDQOL-SF36)
Quality of life will be measured by analyzing KDQOL-SF36
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startDec 2012
- Primary completion14 Feb 2017
- Study completion28 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease / HemodialysisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Clinical Trial Center Wuerzburg (CTCW)
- Responsible party
- Sponsor
- Investigators
- Christoph Wanner, MD, Principal investigator, Wuerzburg University HospitalFabian Hammer, MD, PhD, Principal investigator, Wuerzburg University HospitalVera Krane, MD, Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691053
- Sponsor's protocol ID
- MN0511_1
- Other IDs
- 2011-003179-12, 01KG1202
- Acronym
- MiREnDa
- Status last verified
- Aug 2019
- First submitted
- 19 Sep 2012
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.
PubMed 33586138Hauser T, Dornberger V, Malzahn U, Grebe SJ, Liu D, Stork S, Nauck M, Friedrich N, Dorr M, Wanner C, Krane V, Hammer F; MiREnDa Study Group; Collaborating investigators (sites). The effect of spironolactone on diastolic function in haemodialysis patients. Int J Cardiovasc Imaging. 2021 Jun;37(6):1927-1936. doi: 10.1007/s10554-021-02176-5. Epub 2021 Feb 5.
PubMed 33544240Grebe SJ, Malzahn U, Donhauser J, Liu D, Wanner C, Krane V, Hammer F. Quantification of left ventricular mass by echocardiography compared to cardiac magnet resonance imaging in hemodialysis patients. Cardiovasc Ultrasound. 2020 Sep 16;18(1):39. doi: 10.1186/s12947-020-00217-y.
PubMed 32938484Hammer F, Krane V, Stork S, Roser C, Hofmann K, Pollak N, Allolio B, Wanner C. Rationale and design of the Mineralocorticoid Receptor Antagonists in End-Stage Renal Disease Study (MiREnDa). Nephrol Dial Transplant. 2014 Feb;29(2):400-5. doi: 10.1093/ndt/gft409. Epub 2013 Oct 28.
PubMed 24166468
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial to Evaluate the Efficacy and Safety of Spironolactone in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01691053
- Acronym / sponsor ID
- MiREnDa / MN0511_1
- Conditions
- End Stage Renal Disease / Hemodialysis
- Keywords
- End stage renal disease, Hemodialysis, Spironolactone, Left ventricular hypertrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Clinical Trial Center Wuerzburg (CTCW)
- Study start
- Dec 2012
- Primary completion
- 14 Feb 2017 (actual)
- Study completion
- 28 Mar 2018 (actual)
- First posted
- 24 Sep 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.
End stage renal disease (ESRD) patients exhibit an extraordinarily high annual mortality. Cardiovascular (CV) causes account for almost half of all-cause mortality. Increased left ventricular mass (LVM) is a common finding in ESRD patients on dialysis and is an independent predictor of survival. Yet, to date there is no established medical treatment to reduce CV morbidity and mortality in ESRD patients on hemodialysis. Blockade of aldosterone action by means of mineralocorticoid receptor antagonists (MRA) provides cardioprotection and improves outcome in heart failure patients. Furthermore, the MRA spironolactone has recently been shown to reduce LVM in patients with mild-to-moderate chronic kidney disease (CKD). The investigators here hypothesize that spironolactone treatment is cardioprotective by reducing LVM in ESRD patients on dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spironolactone | Active comparator | Drug: Spironolactone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- Hemodialysis treatment for at least 3 months
- At least 3 dialysis sessions per week
- Written informed consent
Key exclusion criteria (11 listed)
- Contraindications for cardiac magnet resonance imaging (CMR)
- Mineralocorticoid receptor antagonist treatment within the last 6 months
- Estimated life expectancy < 12 months as judged by the nephrologist
- History of hyperkalemia, defined as pre-dialysis potassium > 6.5 mmol/l occurring ≥ 3 times within the last 3 months prior to enrolment.
- High risk to develop hyperkalemia defined as pre-dialysis potassium > 6.0 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 |
|---|---|---|
| Spironolactone50mg once daily | Drug | Spironolactone |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Left Ventricular Mass Index
Time frame: 9 months
as assessed by cardiac MRI
9 secondary outcomes
Cardiac function parameters
Time frame: 9 months
Office and 24h blood pressure
Time frame: 9 months
Clinical measures of heart failure severity
Time frame: 9 months
Vascular function
Time frame: 9 months
Biomarkers of heart failure, inflammation and fibrosis
Time frame: 9 months
Quality of Life - Hospital Anxiety and Depression Scale (HADS)
Time frame: 9 months
Cardiac death and/or hospitalization for heart failure
Time frame: 9 months
Safety measures
Time frame: 9 months
Quality of Life - Kidney Disease Quality of Life Instrument (KDQOL-SF36)
Time frame: 9 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 6 Aug 2019.
- Derived from this study: PubMed 33586138Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.
- Derived from this study: PubMed 33544240Hauser T, Dornberger V, Malzahn U, Grebe SJ, Liu D, Stork S, Nauck M, Friedrich N, Dorr M, Wanner C, Krane V, Hammer F; MiREnDa Study Group; Collaborating investigators (sites). The effect of spironolactone on diastolic function in haemodialysis patients. Int J Cardiovasc Imaging. 2021 Jun;37(6):1927-1936. doi: 10.1007/s10554-021-02176-5. Epub 2021 Feb 5.
- Derived from this study: PubMed 32938484Grebe SJ, Malzahn U, Donhauser J, Liu D, Wanner C, Krane V, Hammer F. Quantification of left ventricular mass by echocardiography compared to cardiac magnet resonance imaging in hemodialysis patients. Cardiovasc Ultrasound. 2020 Sep 16;18(1):39. doi: 10.1186/s12947-020-00217-y.
- Derived from this study: PubMed 24166468Hammer F, Krane V, Stork S, Roser C, Hofmann K, Pollak N, Allolio B, Wanner C. Rationale and design of the Mineralocorticoid Receptor Antagonists in End-Stage Renal Disease Study (MiREnDa). Nephrol Dial Transplant. 2014 Feb;29(2):400-5. doi: 10.1093/ndt/gft409. Epub 2013 Oct 28.
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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.
Christoph Wanner, MD principal investigator
Wuerzburg University Hospital
Fabian Hammer, MD, PhD principal investigator
Wuerzburg University Hospital
Vera Krane, MD principal investigator
Wuerzburg University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spironolactone in people with End Stage Renal Disease / Hemodialysis, run by Wuerzburg University Hospital at 3 sites in Germany.
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 11 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 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Left Ventricular Mass Index (time frame: 9 months). 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 NCT01691053, which also lists 4 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 6 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.