End Stage Renal DiseasePhase 2/3NCT01922999
Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders
A Phase 2/3 study testing Melatonin in people with End Stage Renal Disease and Chronic Kidney Disease, run by Southeast Renal Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- End Stage Renal Disease, Chronic Kidney Disease, Sleep Disorder
- What is being tested?
- Melatonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Southeast Renal Research Institute
Chattanooga, Tennessee, 37408
James A Tumlin, MD, 423-826-8003, jamestumlinmd@nephassociates.com
Jeremy Whitson, 423-826-8003, jeremywhitson@nephassociates.com
About this study
Official title: A Randomized, Prospective, Double Blind, Placebo-Controlled Trial of Two Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders
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.
Read the detailed 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.
- Being tested
- Melatonin
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
patients will receive placebo, 1mg melatonin or 3mg melatonin
| Study group | Role | What they receive |
|---|---|---|
| Placebo controlled | Active comparator | comparison of placebo controlled to 1mg melatonin or 3mg melatonin Receives: Drug: Melatonin |
| Melatonin | Active comparator | comparison of melatonin 1mg or melatonin 3mg Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
Patients taking melatonin supplement, 1mg or 3mg daily, compared to placebo controlled group will be compared to see who group achieved a 25% reduction in sleep latency or 25% increase in total sleep time at the end of 60 days. Using the Pittsburg Sleep Quality Index (PSQI) questionnaire as the index to measure quality of sleep and sleep patterns. Study will also use Polysomnography testing that will record duration of sleep patterns.
Measured: Compare sleep duration at the end of 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast Renal Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James A Tumlin, MD, Principal investigator, Southeast Renal Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922999
- Sponsor's protocol ID
- Melatonin
- Status last verified
- Jan 2017
- First submitted
- 7 Aug 2013
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Double Blind, Placebo-Controlled Trial of Two Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders
- ClinicalTrials.gov ID
- NCT01922999
- Acronym / sponsor ID
- Melatonin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Southeast Renal Research InstituteUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo controlled | Active comparator | Drug: Melatonincomparison of placebo controlled to 1mg melatonin or 3mg melatonin |
| Melatonin | Active comparator | Drug: Melatonincomparison of melatonin 1mg or melatonin 3mg |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatoninpatients will receive placebo, 1mg melatonin or 3mg melatonin | Drug | Melatonin, Placebo controlled |
Primary outcome
Primary Objective
Time frame: Compare sleep duration at the end of 60 days
Patients taking melatonin supplement, 1mg or 3mg daily, compared to placebo controlled group will be compared to see who group achieved a 25% reduction in sleep latency or 25% increase in total sleep time at the end of 60 days. Using the Pittsburg Sleep Quality Index (PSQI) questionnaire as the index to measure quality of sleep and sleep patterns. Study will also use Polysomnography testing that will record duration of sleep patterns.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
Related trials for End Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A Tumlin, MD principal investigator
Southeast Renal Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Melatonin in people with End Stage Renal Disease and Chronic Kidney Disease, run by Southeast Renal Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James A Tumlin, MD (423-826-8003, jamestumlinmd@nephassociates.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: Compare sleep duration at the end of 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.