Usual Diet & Coenzyme Q10 for Kidney Transplant

University of California San Francisco, San Francisco, CA
Kidney Transplantcoenzyme Q10 - DietarySupplement
All Sexes

Study Summary

This trial will test whether watermelon and/or coenzyme Q supplementation is safe and improves kidney function in patients after a kidney transplant.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: Baseline to 20 weeks

At 20 weeks (cross-sectional)
Amount of interstitial fibrosis and tubular atrophy
Baseline to 20 weeks
Change in kidney function (eGFR) over a 20 week period
Changes in amount of protein excretion in the urine over a 20-week period
Mean change in weight from baseline to 20 weeks
Week 20
Number of patients who complete the study after randomized assignment
Measured from 0-20 weeks
Number of participants who develop adverse safety events (including low systolic blood pressure or hyperkalemia) during participation in the study
Measures from 0-20 weeks
Number of participants who are adherent by pill count to coenzyme Q10

Trial Safety

Phase-Based Safety

1 of 3

Trial Design

4 Treatment Groups

Usual Diet & Coenzyme Q10
1 of 4
Watermelon Diet & Coenzyme Q10
1 of 4
Usual Diet & Placebo
1 of 4
Watermelon Diet & Placebo
1 of 4

Active Control

Non-Treatment Group

84 Total Participants · 4 Treatment Groups

Primary Treatment: Usual Diet & Coenzyme Q10 · Has Placebo Group · N/A

Usual Diet & Coenzyme Q10ActiveComparator Group · 2 Interventions: coenzyme Q10, Usual Diet · Intervention Types: DietarySupplement, Other
Usual Diet & PlaceboPlaceboComparator Group · 2 Interventions: Placebo, Usual Diet · Intervention Types: Other, Other
Watermelon Diet & Coenzyme Q10ActiveComparator Group · 2 Interventions: coenzyme Q10, Watermelon diet · Intervention Types: DietarySupplement, Other
Watermelon Diet & PlaceboPlaceboComparator Group · 2 Interventions: Watermelon diet, Placebo · Intervention Types: Other, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 20 weeks

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,347 Previous Clinical Trials
11,783,028 Total Patients Enrolled
Elaine KuPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
63 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You had a kidney transplant within the last four weeks.
You are not currently following a high-watermelon diet or taking co-enzyme Q10 supplements.
You are not very thin, with a body mass index of less than 19 kg/m2.

Frequently Asked Questions

How many participants has this trial recruited thus far?

"Affirmative. contains information showing that this research investigation is currently recruiting patients, having first been published on November 15th 2021 with the most recent amendment dated March 21st 2022. 84 participants are required between a single site of enrolment." - Anonymous Online Contributor

Unverified Answer

Is this investigation open to participants at present?

"Affirmative. displays that this research study, which was first published on November 15th 2021, is currently recruiting participants. 84 volunteers must be sourced from a single clinical centre." - Anonymous Online Contributor

Unverified Answer

What is the primary goal of this clinical experiment?

"The primary outcome measure of this 20-week clinical trial is the number of patients who develop any adverse safety events, including hypotension and hyperkalemia. Secondary objectives involve tracking changes to kidney function as measured by eGFR (in mL/min/1.73m2), monitoring variations in urine protein/creatinine ratio (g/g) over time, and assessing the degree of interstitial fibrosis or tubular atrophy on a biopsy specimen." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.