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

S

Southeast Renal Research Institute

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Chronic Kidney Disease
Sleep Disorder
End Stage Renal Disease

Treatments

Drug: Melatonin

Study type

Interventional

Funder types

Other

Identifiers

NCT01922999
Melatonin

Details and patient eligibility

About

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.

Full description

The study will look at the safety and efficacy of melatonin supplementation given to patients with chronic kidney disease and end stage renal disease who have 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.

Enrollment

53 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

53 participants in 2 patient groups

Placebo controlled
Active Comparator group
Description:
comparison of placebo controlled to 1mg melatonin or 3mg melatonin
Treatment:
Drug: Melatonin
Melatonin
Active Comparator group
Description:
comparison of melatonin 1mg or melatonin 3mg
Treatment:
Drug: Melatonin

Trial contacts and locations

1

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Central trial contact

James A Tumlin, MD; Jeremy Whitson

Data sourced from clinicaltrials.gov

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