Renal Function in Chronic Kidney Disease and the Effect of Exogenous Melatonin Administration (REM TRIAL)

University of Oklahoma1 site in 1 country31 target enrollmentJuly 1, 2019

ConditionsChronic Kidney Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Kidney Diseases
Sponsor: University of Oklahoma
Enrollment: 31
Locations: 1
Primary Endpoint: Change in Albuminuria
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This will be a prospective, double blinded, randomized, controlled pilot study to determine if there is any correlation between melatonin administration and proteinuria.

Detailed Description

Investigators plan to enroll up to 100 eligible participants in this pilot trial with 50 participants randomized to receive melatonin and 50 patients randomized to receive a placebo. Participants will be randomized on a rolling basis; meaning, once participants agree to enroll in the study, the participant will be placed randomly into either group.

Registry

clinicaltrials.gov

Start Date

July 1, 2019

End Date

May 13, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Oklahoma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Are between ages 18 and up with chronic kidney disease (CKD) I-III (stage 3 kidney disease, kidney dysfunction)
•Random urine microalbumin of 30 mcg or greater (protein in the urine)
•Have ability to complete a sleep survey
•Currently not on melatonin therapy.