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Mineralocorticoid Receptor Antagonists in End Stage Renal Disease (MiREnDa)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01691053
Recruitment Status : Completed
First Posted : September 24, 2012
Last Update Posted : January 19, 2018
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease / Hemodialysis Drug: Spironolactone Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Trial to Evaluate the Efficacy and Safety of Spironolactone in Hemodialysis Patients
Study Start Date : December 2012
Primary Completion Date : February 14, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Spironolactone Drug: Spironolactone
50mg once daily
Placebo Comparator: Placebo Drug: Placebo
Placebo


Outcome Measures

Primary Outcome Measures :
  1. Left Ventricular Mass Index [ Time Frame: 9 months ]
    as assessed by cardiac MRI


Secondary Outcome Measures :
  1. Cardiac function parameters [ Time Frame: 9 months ]
    cardiac volumes, systolic and diastolic function, cardiac output as measured by cardiac MRI and echocardiography

  2. Office and 24h blood pressure [ Time Frame: 9 months ]
  3. Clinical measures of heart failure severity [ Time Frame: 9 months ]
    New York Heart Association (NYHA) functional class, 6 minute walk test

  4. Vascular function [ Time Frame: 9 months ]
    Carotid intima meda thickness, pulse wave analysis, carotid artery distensibility, flow mediated dilatation of the brachial artery

  5. Biomarkers of heart failure, inflammation and fibrosis [ Time Frame: 9 months ]
  6. Quality of Life [ Time Frame: 9 months ]
  7. Cardiac death and/or hospitalization for heart failure [ Time Frame: 9 months ]
  8. Safety measures [ Time Frame: 9 months ]
    Pre-dialysis potassium levels, frequency of hyperkalemic episodes (K>6.5mmol/l), measurement of residual kidney function (if applicable)


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 years
  • Hemodialysis treatment for at least 3 months
  • At least 3 dialysis sessions per week
  • Written informed consent

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691053


Locations
Germany
University Hospital Erlangen-Nürnberg
Erlangen, Germany, 91054
University Hospital Frankfurt
Frankfurt, Germany, 60590
University Hospital Wuerzburg
Wuerzburg, Germany, 97080
Sponsors and Collaborators
Wuerzburg University Hospital
German Federal Ministry of Education and Research
Clinical Trial Center Wuerzburg (CTCW)
Investigators
Principal Investigator: Christoph Wanner, MD University Hospital Wuerzburg
Principal Investigator: Fabian Hammer, MD, PhD University Hospital Wuerzburg
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT01691053     History of Changes
Other Study ID Numbers: MN0511_1
2011-003179-12 ( EudraCT Number )
01KG1202 ( Other Grant/Funding Number: German Ministry of Education and Research )
First Posted: September 24, 2012    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: February 2014

Keywords provided by Wuerzburg University Hospital:
End stage renal disease
Hemodialysis
Spironolactone
Left ventricular hypertrophy

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Spironolactone
Mineralocorticoid Receptor Antagonists
Mineralocorticoids
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Hormones