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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK089503 | U.S. NIH Grant/Contract | View source |
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Lack of funding
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caloric Intake Reduction | Experimental | 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. |
|
| Standard of care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| caloric intake reduction | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the Change in Baseline and 3 Month Glomerular Volume Between the Intervention and the Control Arm | 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 | 3 month protocol biopsies will be stained with monoclonal antibodies against Ki67 to identify actively dividing cells and counted manually. | 3 months |
| Difference in the Number of Glomerular DAPI Positive (Nuclei) Between the Intervention and the Control Arm | 3 month protocol biopsies will be stained with monoclonal antibodies against DAPI to identify nucleated cells in the glomerulus and counted manually. | 3 months |
| Difference in the Number of TLE4 Positive (Podocyte Nuclei) Between the Intervention and the Control Arm | 3 month protocol biopsies will be stained with monoclonal antibodies against TLE4 to identify podocytes and counted manually. | 3 months |
| Differences in Podocyte Detachment Rate Between the Intervention and the Control Arm | Urine samples obtained at the time of 3-month protocol biopsies will be utilized to compare the urinary podocin mRNA to urinary creatinine ratio | 3 months |
| Difference in the Podocyte Hypertrophic Stress Between the Intervention and the Control Arm | Urine samples obtained at the time of 3-month protocol biopsies will be utilized to compare the urinary podocin mRNA to nephrin mRNA ratio | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Glomerular Filtration Rate (GFR) at 3 and 12 Months Between the Intervention and the Control Arm | Differences in glomerular filtration rate (GFR) using both creatinine (modified diet in renal disease) as well as serum cystatin C based equations | 3 months, 12 months |
| Difference in Proteinuria Between the Intervention and the Control Arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abhijit Naik, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only one participant was involved in the entire trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in the Change in Baseline and 3 Month Glomerular Volume Between the Intervention and the Control Arm | 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. | Posted | Post-Perfusion (Time 0 or Study Enrollment) and 3 months |
|
Through each participant's study completion, typically 3 months
Participant had no SAEs or AEs and outlived the trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abhijit Naik | University of Michigan | 734-763-0990 | abhinaik@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 23, 2019 | Nov 4, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Proteinuria measured by laboratory samples |
| Measured through study completion, about 3 months |
| Difference in Glycosylated Hemoglobin (HbA1c) Percent in the Intervention and the Control Arms | Measure the difference in HbA1c between the two arms during 3 month protocol biopsies | 3 months |
| Difference in Weight of Participants in the Intervention and Control Arms | Weight as measured by pounds | 3 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
|
| Primary | Difference in the Number of Glomerular Ki67 Positive Cells Between the Intervention and the Control Arm | 3 month protocol biopsies will be stained with monoclonal antibodies against Ki67 to identify actively dividing cells and counted manually. | 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. | Posted | 3 months |
|
|
| Primary | Difference in the Number of Glomerular DAPI Positive (Nuclei) Between the Intervention and the Control Arm | 3 month protocol biopsies will be stained with monoclonal antibodies against DAPI to identify nucleated cells in the glomerulus and counted manually. | 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. | Posted | 3 months |
|
|
| Primary | Difference in the Number of TLE4 Positive (Podocyte Nuclei) Between the Intervention and the Control Arm | 3 month protocol biopsies will be stained with monoclonal antibodies against TLE4 to identify podocytes and counted manually. | 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. | Posted | 3 months |
|
|
| Primary | Differences in Podocyte Detachment Rate Between the Intervention and the Control Arm | Urine samples obtained at the time of 3-month protocol biopsies will be utilized to compare the urinary podocin mRNA to urinary creatinine ratio | 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. | Posted | 3 months |
|
|
| Primary | Difference in the Podocyte Hypertrophic Stress Between the Intervention and the Control Arm | Urine samples obtained at the time of 3-month protocol biopsies will be utilized to compare the urinary podocin mRNA to nephrin mRNA ratio | 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. | Posted | 3 months |
|
|
| Secondary | Difference in Glomerular Filtration Rate (GFR) at 3 and 12 Months Between the Intervention and the Control Arm | Differences in glomerular filtration rate (GFR) using both creatinine (modified diet in renal disease) as well as serum cystatin C based equations | 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. | Posted | 3 months, 12 months |
|
|
| Secondary | Difference in Proteinuria Between the Intervention and the Control Arm | Proteinuria measured by laboratory samples | 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. | Posted | Measured through study completion, about 3 months |
|
|
| Secondary | Difference in Glycosylated Hemoglobin (HbA1c) Percent in the Intervention and the Control Arms | Measure the difference in HbA1c between the two arms during 3 month protocol biopsies | 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. | Posted | 3 months |
|
|
| Secondary | Difference in Weight of Participants in the Intervention and Control Arms | Weight as measured by pounds | 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. | Posted | 3 months |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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