Kidney Transplant; ComplicationsNCT03607500
Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation
A study testing caloric intake reduction in people with Kidney Transplant; Complications and Glomerular Disease, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplant; Complications, Glomerular Disease, Weight Gain
- What is being tested?
- caloric intake reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2019to 16 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients on dual anti platelet agents or are on oral anti coagulation medication
- Patients who have had Bariatric Surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
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.
- Being tested
- caloric intake reduction
- Keywords
- Caloric Intake Reduction, Dietician
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caloric intake reductionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: caloric intake reduction |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the Change in Baseline and 3 Month Glomerular Volume Between the Intervention and the Control Arm
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 3 months
Secondary outcomes (4)
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
Measured: 3 months, 12 months
Difference in Proteinuria Between the Intervention and the Control Arm
Proteinuria measured by laboratory samples
Measured: 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
Measured: 3 months
Difference in Weight of Participants in the Intervention and Control Arms
Weight as measured by pounds
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start22 Aug 2019
- Primary completion16 Aug 2021
- Study completion16 Aug 2021
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhijit Naik, University of Michigan
- Investigators
- Abhijit Naik, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607500
- Sponsor's protocol ID
- HUM00134686
- Other IDs
- P30DK089503
- Status last verified
- Jan 2023
- First submitted
- 20 Jul 2018
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT03607500
- Acronym / sponsor ID
- HUM00134686
- Keywords
- Caloric Intake Reduction, Dietician
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Posted 8 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caloric Intake Reduction | Experimental | Behavioral: caloric intake reductionThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients on dual anti platelet agents or are on oral anti coagulation medication
- Patients who have had Bariatric Surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caloric intake reductionThe 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). | Behavioural | Caloric Intake Reduction |
Primary outcome
Difference in the Change in Baseline and 3 Month Glomerular Volume Between the Intervention and the Control Arm
Time frame: 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
Time frame: 3 months
3 month protocol biopsies will be stained with monoclonal antibodies against Ki67 to identify actively dividing cells and counted manually.
Difference in the Number of Glomerular DAPI Positive (Nuclei) Between the Intervention and the Control Arm
Time frame: 3 months
3 month protocol biopsies will be stained with monoclonal antibodies against DAPI to identify nucleated cells in the glomerulus and counted manually.
Difference in the Number of TLE4 Positive (Podocyte Nuclei) Between the Intervention and the Control Arm
Time frame: 3 months
3 month protocol biopsies will be stained with monoclonal antibodies against TLE4 to identify podocytes and counted manually.
Differences in Podocyte Detachment Rate Between the Intervention and the Control Arm
Time frame: 3 months
Urine samples obtained at the time of 3-month protocol biopsies will be utilized to compare the urinary podocin mRNA to urinary creatinine ratio
Difference in the Podocyte Hypertrophic Stress Between the Intervention and the Control Arm
Time frame: 3 months
Urine samples obtained at the time of 3-month protocol biopsies will be utilized to compare the urinary podocin mRNA to nephrin mRNA ratio
4 secondary outcomes
Difference in Glomerular Filtration Rate (GFR) at 3 and 12 Months Between the Intervention and the Control Arm
Time frame: 3 months, 12 months
Difference in Proteinuria Between the Intervention and the Control Arm
Time frame: Measured through study completion, about 3 months
Difference in Glycosylated Hemoglobin (HbA1c) Percent in the Intervention and the Control Arms
Time frame: 3 months
Difference in Weight of Participants in the Intervention and Control Arms
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abhijit Naik, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caloric intake reduction in people with Kidney Transplant; Complications and Glomerular Disease, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the Change in Baseline and 3 Month Glomerular Volume Between the Intervention and the Control Arm (time frame: Post-Perfusion (Time 0 or Study Enrollment) and 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.