TerminatedNot Applicable

Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation

Stopped: Lack of funding

United States1 participantsStarted 2019-08-22

Plain-language summary

One possible reason that weight gain after transplant may interfere with new kidney function is due to the enlargement of a kidney structure called the glomerulus. The researchers believe that modest caloric intake reduction (CIR) early after kidney transplantation can reduce the enlargement (hypertrophy) of the glomerulus associated with kidney transplantation and may improve long term allograft survival, by reducing glomerular hypertrophy mediated progressive glomerulosclerosis.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Recipients of kidney transplants where a post perfusion biopsy is obtained * Body Mass Index between 25-30 kg/m2 at the time of randomization * Non-diabetic * Have a smart phone or active internet connection at home Exclusion Criteria: * Patients on dual anti platelet agents or are on oral anti coagulation medication * Patients who have had Bariatric Surgery

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in the Change in Baseline and 3 Month Glomerular Volume Between the Intervention and the Control Arm

Timeframe: Post-Perfusion (Time 0 or Study Enrollment) and 3 months

Difference in the Number of Glomerular Ki67 Positive Cells Between the Intervention and the Control Arm

Timeframe: 3 months

Difference in the Number of Glomerular DAPI Positive (Nuclei) Between the Intervention and the Control Arm

Timeframe: 3 months

Difference in the Number of TLE4 Positive (Podocyte Nuclei) Between the Intervention and the Control Arm

Timeframe: 3 months

Differences in Podocyte Detachment Rate Between the Intervention and the Control Arm

Timeframe: 3 months

Difference in the Podocyte Hypertrophic Stress Between the Intervention and the Control Arm

Timeframe: 3 months

Trial details

NCT IDNCT03607500

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-16

Results submitted2022-11-11

View on ClinicalTrials.gov More Kidney Transplant; Complications trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Difference in the Change in Baseline and 3 Month Glomerular Volume Between the Intervention and the Control Arm

Timeframe: Post-Perfusion (Time 0 or Study Enrollment) and 3 months

Difference in the Number of Glomerular Ki67 Positive Cells Between the Intervention and the Control Arm

Timeframe: 3 months

Difference in the Number of Glomerular DAPI Positive (Nuclei) Between the Intervention and the Control Arm

Timeframe: 3 months

Difference in the Number of TLE4 Positive (Podocyte Nuclei) Between the Intervention and the Control Arm

Timeframe: 3 months

Differences in Podocyte Detachment Rate Between the Intervention and the Control Arm

Timeframe: 3 months

Difference in the Podocyte Hypertrophic Stress Between the Intervention and the Control Arm

Timeframe: 3 months