Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006408

Trial Description

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Title

Phase II Trial to Evaluate the Efficacy and Safety of Spironolactone in Hemodialysis Patients

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Trial Acronym

MiREnDa

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006408
  •   2014/12/02
  •   2012/09/19
  •   yes
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Secondary IDs

  •   2011-003179-12 
  •   NCT01691053  (ClinicalTrials.gov)
  •   MN0511_1  (Wuerzburg University Hospital)
  •   2011-003179-12 
  •   01KG1202 
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Health Condition or Problem studied

  •   End Stage Renal Disease / Hemodialysis
  •   N18.5 -  Chronic kidney disease, stage 5
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Interventions/Observational Groups

  •   Drug: Spironolactone
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo, Active control
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Left Ventricular Mass Index; time frame: 9 months; as assessed by cardiac MRI

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Secondary Outcome

- Cardiac function parameters; time frame: 9 months; cardiac volumes, systolic and diastolic function, cardiac output as measured by cardiac MRI and echocardiography
- Office and 24h blood pressure; time frame: 9 months
- Clinical measures of heart failure severity; time frame: 9 months; New York Heart Association (NYHA) functional class, 6 minute walk test
- Vascular function; time frame: 9 months; Carotid intima meda thickness, pulse wave analysis, carotid artery distensibility, flow mediated dilatation of the brachial artery
- Biomarkers of heart failure, inflammation and fibrosis; time frame: 9 months
- Quality of Life; time frame: 9 months
- Cardiac death and/or hospitalization for heart failure; time frame: 9 months
- 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)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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  •  
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Recruitment

  •   [---]*
  •   2012/12/31
  •   120
  •   Multicenter trial
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Age >18 years

- Hemodialysis treatment for at least 3 months

- At least 3 dialysis sessions per week

- Written informed consent

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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

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Addresses

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    • Wuerzburg University Hospital
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    • German Federal Ministry of Education and Research
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    • Clinical Trial Center Wuerzburg (CTCW)
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    •   [---]*
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    • University Hospital Wuerzburg
    • Christoph Wanner, MD 
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    • Fabian Hammer, MD, PhD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.