Trial Outcomes & Findings for Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation (NCT NCT03607500)
NCT ID: NCT03607500
Last Updated: 2023-02-08
Results Overview
TERMINATED
NA
1 participants
Post-Perfusion (Time 0 or Study Enrollment) and 3 months
2023-02-08
Participant Flow
Participant milestones
| Measure |
Caloric Intake Reduction
The intervention group will be seen by the kidney disease dietician at all clinical visits for the first 3 months (weekly for month 1, every other week for months 2 and 3). During months 2 and 3, in the weeks that the patients are not in clinic, they will receive telephone calls from the dietician. Thus the intervention involves weekly assessment for the first 3 months (in person or over the telephone). After 3 months, the patient will not receive any further active dietary intervention from the dieticians unless the patient wishes to continue using the dieticians advice per clinic protocol.
caloric intake reduction: The caloric intake reduction arm will been seen by the kidney disease dietitian at all clinical visits for the first 3 months (weekly for month 1, every other week for months 2 and 3).
|
Standard of Care
The standard of care arm will receive dietary guidance per current University of Michigan Transplant Center policy, where a one time face-to-face visit is provided in the first month after kidney transplant and then as requested by the patient or referred by physician.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation
Baseline characteristics by cohort
| Measure |
Caloric Intake Reduction
n=1 Participants
The intervention group will be seen by the kidney disease dietician at all clinical visits for the first 3 months (weekly for month 1, every other week for months 2 and 3). During months 2 and 3, in the weeks that the patients are not in clinic, they will receive telephone calls from the dietician. Thus the intervention involves weekly assessment for the first 3 months (in person or over the telephone). After 3 months, the patient will not receive any further active dietary intervention from the dieticians unless the patient wishes to continue using the dieticians advice per clinic protocol.
caloric intake reduction: The caloric intake reduction arm will been seen by the kidney disease dietitian at all clinical visits for the first 3 months (weekly for month 1, every other week for months 2 and 3).
|
Standard of Care
The standard of care arm will receive dietary guidance per current University of Michigan Transplant Center policy, where a one time face-to-face visit is provided in the first month after kidney transplant and then as requested by the patient or referred by physician.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-Perfusion (Time 0 or Study Enrollment) and 3 monthsPopulation: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 monthsPopulation: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
3 month protocol biopsies will be stained with monoclonal antibodies against Ki67 to identify actively dividing cells and counted manually.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 monthsPopulation: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
3 month protocol biopsies will be stained with monoclonal antibodies against DAPI to identify nucleated cells in the glomerulus and counted manually.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 monthsPopulation: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
3 month protocol biopsies will be stained with monoclonal antibodies against TLE4 to identify podocytes and counted manually.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 monthsPopulation: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
Urine samples obtained at the time of 3-month protocol biopsies will be utilized to compare the urinary podocin mRNA to urinary creatinine ratio
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 monthsPopulation: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
Urine samples obtained at the time of 3-month protocol biopsies will be utilized to compare the urinary podocin mRNA to nephrin mRNA ratio
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months, 12 monthsPopulation: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
Differences in glomerular filtration rate (GFR) using both creatinine (modified diet in renal disease) as well as serum cystatin C based equations
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured through study completion, about 3 monthsPopulation: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
Proteinuria measured by laboratory samples
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
Measure the difference in HbA1c between the two arms during 3 month protocol biopsies
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
Weight as measured by pounds
Outcome measures
Outcome data not reported
Adverse Events
Caloric Intake Reduction
Standard of Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place