Renal Effects of Melatonin Trial in Chronic Kidney Disease

Renal Function in Chronic Kidney Disease and the Effect of Exogenous Melatonin Administration (REM TRIAL)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04336566

Acronym

REM

Enrollment

Registered

2020-04-07

Start date

2019-07-01

Completion date

2020-05-13

Last updated

2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney Disease

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTMelatonin

Melatonin 5mg

DIETARY_SUPPLEMENTPlacebo

Comparable Good Neighbor Pharmacy placebo tablet

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Participant, care provider, data manager/monitor, principle investigator all blinded

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* End Stage Renal Disease * CKD Stage IV (stage 4 with severe kidney dysfunction) * Severe liver disease * Chronic dialysis therapy

Design outcomes

Primary

Measure	Time frame	Description
Change in Albuminuria	6 months	protein in urine

Secondary

Measure	Time frame	Description
Blood Urea Nitrogen (BUN) levels	6 months	Blood Urea Nitrogen
Potassium levels	6 months	mineral in blood
Bicarbonate levels	6 months	base found in blood
Creatinine levels	6 months	serum blood
Sodium levels	6 months	electrolyte in blood
Urinalysis	6 months	To asses electrolyte and protein levels
Chloride levels	6 months	electrolyte in blood
Surveys including Pittsburgh Sleep Quality Index (PSQI) questionnaire	6 months	Scale 0-21, higher scores indicate worse sleep quality

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026