Mineralocorticoid Receptor Antagonists in End Stage Renal Disease
MiREnDa
Phase II Trial to Evaluate the Efficacy and Safety of Spironolactone in Hemodialysis Patients
3 other identifiers
interventional
118
1 country
3
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2012
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2012
CompletedFirst Posted
Study publicly available on registry
September 24, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2018
CompletedAugust 6, 2019
August 1, 2019
4.2 years
September 19, 2012
August 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Left Ventricular Mass Index
as assessed by cardiac MRI
9 months
Secondary Outcomes (9)
Cardiac function parameters
9 months
Office and 24h blood pressure
9 months
Clinical measures of heart failure severity
9 months
Vascular function
9 months
Biomarkers of heart failure, inflammation and fibrosis
9 months
- +4 more secondary outcomes
Study Arms (2)
Spironolactone
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age \>18 years
- Hemodialysis treatment for at least 3 months
- At least 3 dialysis sessions per week
- Written informed consent
You may not qualify if:
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University Hospital Erlangen-Nürnberg
Erlangen, 91054, Germany
University Hospital Frankfurt
Frankfurt, 60590, Germany
University Hospital Wuerzburg
Würzburg, 97080, Germany
Related Publications (4)
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.
PMID: 33586138DERIVEDHauser 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.
PMID: 33544240DERIVEDGrebe 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.
PMID: 32938484DERIVEDHammer 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.
PMID: 24166468DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Wanner, MD
University Hospital Wuerzburg
- PRINCIPAL INVESTIGATOR
Fabian Hammer, MD, PhD
University Hospital Wuerzburg
- PRINCIPAL INVESTIGATOR
Vera Krane, MD
University Hospital Wuerzburg
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2012
First Posted
September 24, 2012
Study Start
December 1, 2012
Primary Completion
February 14, 2017
Study Completion
March 28, 2018
Last Updated
August 6, 2019
Record last verified: 2019-08