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Hormone Therapy

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

Phase 2 & 3
Waitlist Available
Led By James A Tumlin, MD
Research Sponsored by Southeast Renal Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up compare sleep duration at the end of 60 days
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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.

Eligible Conditions
  • Sleep Disorders
  • Kidney Failure
  • Chronic Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~compare sleep duration at the end of 60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and compare sleep duration at the end of 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Objective

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Placebo controlledActive Control1 Intervention
comparison of placebo controlled to 1mg melatonin or 3mg melatonin
Group II: MelatoninActive Control1 Intervention
comparison of melatonin 1mg or melatonin 3mg

Find a Location

Who is running the clinical trial?

Southeast Renal Research InstituteLead Sponsor
6 Previous Clinical Trials
45 Total Patients Enrolled
James A Tumlin, MDPrincipal InvestigatorSoutheast Renal Research Institute
6 Previous Clinical Trials
1,030 Total Patients Enrolled
~4 spots leftby Dec 2025
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