Recruiting
Phase 2
Phase 3

Melatonin

Sponsor:

Southeast Renal Research Institute

Code:

NCT01922999

Conditions

End Stage Renal Disease

Chronic Kidney Disease

Sleep Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Melatonin

Study Details

Brief summary:

The study will evaluate the safety and efficacy of melatonin supplementation in CKD and ESRD patients with sleep disorders to reduce sleep latency times, the number of apnea/hypopneic episodes, and prolong duration in rapid eye movement (REM) sleep in CKD and ESRD patients with sleep disordered breathing.

Conditions

End Stage Renal Disease

Chronic Kidney Disease

Sleep Disorder

Study ID

NCT01922999

Start date

Dec, 2012

Status verified date

Jan, 2017

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Patient age > 18 and <85 years of age
2. Patients with CKD or ESRD with eGFR < 30 mls/min
3. If receiving hemodialysis, patients must be on treatment > 3 months
4. Normal healthy controls must be without a known history of CKD and be willing to have formal PSG test and plasma melatonin measurements

Exclusion Criteria:

1. Patients receiving outpatient hemodialysis for < 3 months
2. Patients with estimated GFR by Cockcroft Gault > 30 mls/min
3. Patients receiving beta blocker therapy within one month of randomization
4. Patients receiving Nifedipine therapy within one month randomization
5. Patients on peritoneal dialysis
6. Patient with chronic home oxygen supplementation
7. Patients receiving chronic home CPAP therapy
8. Patients actively receiving outpatient sleep medications
9. Patients with diabetic gastroparesis unresponsive to medication
10. Patients with known pregnancy or unwilling to use contraception during the course of the study
11. Patients with a functioning renal allograft
12. Patient currently receiving long-term immunosuppressive therapy. Patients receiving low dose prednisone (10mg or less per day) will not be excluded from this trial
13. Unable to give informed consent

Study Design

Enrollment

53 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Placebo controlled

comparison of placebo controlled to 1mg melatonin or 3mg melatonin

active comparator: Melatonin

comparison of melatonin 1mg or melatonin 3mg

Interventions

Melatonin

patients will receive placebo, 1mg melatonin or 3mg melatonin

Primary outcome measure

  • Primary Objective [ Time Frame: Compare sleep duration at the end of 60 days ]

Central Contacts and Locations

Central contacts

James A Tumlin, MD

423-826-8003jamestumlinmd@nephassociates.com

Jeremy Whitson

423-826-8003jeremywhitson@nephassociates.com

Locations

Southeast Renal Research Institute

Recruiting

Chattanooga, Tennessee, United States, 37408

Contacts

James A Tumlin, MD

423-826-8003jamestumlinmd@nephassociates.com

Jeremy Whitson

423-826-8003jeremywhitson@nephassociates.com

Principal Investigator:

James A Tumlin, MD

More Information

Sponsor

Southeast Renal Research Institute

Last update posted

Jan 24, 2017

Last verified

Jan, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Southeast Renal Research Institute on 2017-01-24.