Chronic Kidney DiseasesREMNCT04336566
Renal Effects of Melatonin Trial in Chronic Kidney Disease
A study testing Melatonin in people with Chronic Kidney Diseases, run by University of Oklahoma at 1 site in United States.
Trial summary
This will be a prospective, double blinded, randomized, controlled pilot study to determine if there is any correlation between melatonin administration and proteinuria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 13 May 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are between ages 18 and up with chronic kidney disease (CKD) I-III (stage 3 kidney disease, kidney dysfunction)
- Random urine microalbumin of 30 mcg or greater (protein in the urine)
- Have ability to complete a sleep survey
- Currently not on melatonin therapy.
Who cannot join
- End Stage Renal Disease
- CKD Stage IV (stage 4 with severe kidney dysfunction)
- Severe liver disease
- Chronic dialysis therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma School of Community Medicine
Tulsa, Oklahoma, 74135
About this study
Official title: Renal Function in Chronic Kidney Disease and the Effect of Exogenous Melatonin Administration (REM TRIAL)
This will be a prospective, double blinded, randomized, controlled pilot study to determine if there is any correlation between melatonin administration and proteinuria.
Read the detailed description
Investigators plan to enroll up to 100 eligible participants in this pilot trial with 50 participants randomized to receive melatonin and 50 patients randomized to receive a placebo. Participants will be randomized on a rolling basis; meaning, once participants agree to enroll in the study, the participant will be placed randomly into either group.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Melatonin, Placebo
- Keywords
- Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
Melatonin 5mg
PlaceboDietary supplement
Comparable Good Neighbor Pharmacy placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Active comparator | 5mg dose of melatonin manufactured by Good Neighbor Pharmacy Receives: Dietary Supplement: Melatonin |
| Placebo | Placebo comparator | Good Neighbor Pharmacy placebo tablet that looks the same without active ingredient Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Albuminuria
protein in urine
Measured: 6 months
Secondary outcomes (8)
Surveys including Pittsburgh Sleep Quality Index (PSQI) questionnaire
Scale 0-21, higher scores indicate worse sleep quality
Measured: 6 months
Sodium levels
electrolyte in blood
Measured: 6 months
Urinalysis
To asses electrolyte and protein levels
Measured: 6 months
Creatinine levels
serum blood
Measured: 6 months
Blood Urea Nitrogen (BUN) levels
Blood Urea Nitrogen
Measured: 6 months
Potassium levels
mineral in blood
Measured: 6 months
Bicarbonate levels
base found in blood
Measured: 6 months
Chloride levels
electrolyte in blood
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 Jul 2019
- Primary completion13 May 2020
- Study completion13 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krishna M Baradhi, MD, Principal investigator, OUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336566
- Sponsor's protocol ID
- 10584
- Acronym
- REM
- Status last verified
- Jul 2020
- First submitted
- 16 Mar 2020
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Function in Chronic Kidney Disease and the Effect of Exogenous Melatonin Administration (REM TRIAL)
- ClinicalTrials.gov ID
- NCT04336566
- Acronym / sponsor ID
- REM / 10584
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 13 May 2020 (actual)
- Study completion
- 13 May 2020 (actual)
- First posted
- 7 Apr 2020 (actual)
- 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.
This will be a prospective, double blinded, randomized, controlled pilot study to determine if there is any correlation between melatonin administration and proteinuria.
Detailed description
Investigators plan to enroll up to 100 eligible participants in this pilot trial with 50 participants randomized to receive melatonin and 50 patients randomized to receive a placebo. Participants will be randomized on a rolling basis; meaning, once participants agree to enroll in the study, the participant will be placed randomly into either group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Active comparator | Dietary Supplement: Melatonin5mg dose of melatonin manufactured by Good Neighbor Pharmacy |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboGood Neighbor Pharmacy placebo tablet that looks the same without active ingredient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are between ages 18 and up with chronic kidney disease (CKD) I-III (stage 3 kidney disease, kidney dysfunction)
- Random urine microalbumin of 30 mcg or greater (protein in the urine)
- Have ability to complete a sleep survey
- Currently not on melatonin therapy.
Key exclusion criteria (4 listed)
- End Stage Renal Disease
- CKD Stage IV (stage 4 with severe kidney dysfunction)
- Severe liver disease
- Chronic dialysis therapy
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 |
|---|---|---|
| MelatoninMelatonin 5mg | Dietary supplement | Melatonin |
| PlaceboComparable Good Neighbor Pharmacy placebo tablet | Dietary supplement | Placebo |
Primary outcome
Change in Albuminuria
Time frame: 6 months
protein in urine
8 secondary outcomes
Surveys including Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time frame: 6 months
Sodium levels
Time frame: 6 months
Urinalysis
Time frame: 6 months
Creatinine levels
Time frame: 6 months
Blood Urea Nitrogen (BUN) levels
Time frame: 6 months
Potassium levels
Time frame: 6 months
Bicarbonate levels
Time frame: 6 months
Chloride levels
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Krishna M Baradhi, MD principal investigator
OUHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Chronic Kidney Diseases, run by University of Oklahoma 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 4 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: finished, as of the sponsor's last update on 3 Aug 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Albuminuria (time frame: 6 months). 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 3 Aug 2020.