Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Southeast Renal Research Institute
• Treatments: Melatonin

Criteria

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