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Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial

NCT02285920 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2019-07-23

Study results available
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Summary

The SPin-D Trial is a phase II randomized, double-blind, placebo-controlled, multi-center study of spironolactone (SPL) for patients with hemodialysis-dependent end-stage renal disease.

Conditions

  • End-Stage Renal Disease

Interventions

DRUG

Spironolactone

The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.

Sponsors & Collaborators

Principal Investigators

  • Laura M Dember, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-06-30
Completion
2017-07-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02285920 on ClinicalTrials.gov