Trial document

This study has been imported from without additional data checks.
drksid header


Trial Description

start of 1:1-Block title


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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym


end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial


end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language


end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006408
  •   2014/12/02
  •   2012/09/19
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2011-003179-12 
  •   NCT01691053  (
  •   MN0511_1  (Wuerzburg University Hospital)
  •   2011-003179-12 
  •   01KG1202 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   End Stage Renal Disease / Hemodialysis
  •   N18.5 -  Chronic kidney disease, stage 5
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: Spironolactone
end of 1:N-Block interventions
start of 1:1-Block design


  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo, Active control
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

end of 1:n-Block recruitment locations
start of 1:1-Block recruitment


  •   [---]*
  •   2012/12/31
  •   120
  •   Multicenter trial
  •   [---]*
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Age >18 years

- Hemodialysis treatment for at least 3 months

- At least 3 dialysis sessions per week

- Written informed consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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,

- Allergy/hypersensitivity to spironolactone

- Non-compliance suspected or demonstrated

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses


  • start of 1:1-Block address primary-sponsor
    • Wuerzburg University Hospital
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • German Federal Ministry of Education and Research
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Clinical Trial Center Wuerzburg (CTCW)
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • University Hospital Wuerzburg
    • Christoph Wanner, MD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Fabian Hammer, MD, PhD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state


  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in and DRKS are not identical. Therefore the data import from 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.