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Clinical Trials/CTRI/2019/06/019703
CTRI/2019/06/019703
Recruiting
Phase 3

Aldosterone blockade for Health Improvement Evaluation in End-stage renal disease - ACHIEVE

Population Health Research Institute0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: N186- End stage renal disease

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: N186- End stage renal disease
Sponsor
Population Health Research Institute
Status
Recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Age \>\=18 with a history of diabetes
  • •2\. On dialysis \>\= 90 days
  • •3\. On either
  • •a. Hemodialysis prescribed at least 2 treatments per week or
  • •b. Peritoneal dialysis prescribed with at least 1 exchange daily
  • •4\. Provides informed consent

Exclusion Criteria

  • •1\. Hyperkalemia
  • •a. Serum potassium \>5\.8 mmol/L in the 6 weeks prior to enrollment or
  • •b. Serum potassium \>6\.0 mmol/L during active run\-in
  • •2\. Currently taking and unable to withdraw a mineralocorticoid receptor
  • •antagonist (i.e. spironolactone or eplerenone).
  • •3\. Known sensitivity or allergy to spironolactone
  • •4\. Current or planned pregnancy or breastfeeding
  • •5\. Scheduled living related donor renal transplant
  • •6\. Life expectancy \< 6 months in the opinion of a treating nephrologist.
  • •7\. Enrolled in another interventional trial testing a mineralocorticoid receptor antagonist or drug that has a known or likely interaction with

Outcomes

Primary Outcomes

Not specified

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