Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders
Status unconfirmed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: End Stage Renal Disease, Chronic Kidney Disease, Sleep Disorder
In brief
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.
Key facts
- Study ID
- NCT01922999
- Run by
- Southeast Renal Research Institute
- People needed
- 53
- Starts
- 2012-12-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2017-01-24
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patient age > 18 and <85 years of age
- Patients with CKD or ESRD with eGFR < 30 mls/min
- If receiving hemodialysis, patients must be on treatment > 3 months
- Normal healthy controls must be without a known history of CKD and be willing to have formal PSG test and plasma melatonin measurements
You may not qualify if…
- Patients receiving outpatient hemodialysis for < 3 months
- Patients with estimated GFR by Cockcroft Gault > 30 mls/min
- Patients receiving beta blocker therapy within one month of randomization
- Patients receiving Nifedipine therapy within one month randomization
- Patients on peritoneal dialysis
- Patient with chronic home oxygen supplementation
- Patients receiving chronic home CPAP therapy
- Patients actively receiving outpatient sleep medications
- Patients with diabetic gastroparesis unresponsive to medication
- Patients with known pregnancy or unwilling to use contraception during the course of the study
- Patients with a functioning renal allograft
- Patient currently receiving long-term immunosuppressive therapy. Patients receiving low dose prednisone (10mg or less per day) will not be excluded from this trial
- Unable to give informed consent
Where it is running
- Southeast Renal Research Institute — Chattanooga, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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