DiabetesHiRTNCT01643382
Hyperglycemia in Renal Transplantation
A study testing Insulin and Insulin, Asp(B28)- in people with Diabetes and End Stage Renal Disease, run by University of California, San Francisco at 1 site in United States.
Trial summary
Based on multiple prior studies, kidney transplant recipients with diabetes are at higher risk for poor initial graft function after transplant. Our study is designed to determine if tight blood sugar control around the time of kidney transplant will improve short term graft function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, End Stage Renal Disease
- What is being tested?
- Insulin and Insulin, Asp(B28)-
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients
- diabetic
- end stage renal disease undergoing cadaveric renal transplant
Who cannot join
- enrolled in concurrent study to test impact of a drug on graft function after transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94123
About this study
Official title: Randomized Study of the Impact of Peri-operative Glucose Control on Short Term Renal Allograft Function After Transplantation
Based on multiple prior studies, kidney transplant recipients with diabetes are at higher risk for poor initial graft function after transplant. Our study is designed to determine if tight blood sugar control around the time of kidney transplant will improve short term graft function.
Read the detailed description
Population- Our study population will include all adult diabetic patients undergoing deceased donor renal transplantation or living donor transplantation in which a swap requires transportation and resulting cold storage time. This will ensure a reasonable incidence of our primary outcome (poor short term graft function) and eliminate the potential risk of treating non-diabetic patients with insulin infusions. Patients already enrolled in a drug trial designed to study the impact of the drug on graft function will be excluded.
Study Design- This will be a randomized control trial. Recipients will be randomized to either tight peri-operative glucose control or standard management.
Methods
Randomization Protocol- In order to ensure that patients are equally distributed between groups, we will use block randomization. Blocks of 4 patients will be created with the total number of experimental versus control assignments being equal across blocks. Patients will then be randomly assigned to a block.
Interventions- The study group will be treated with an insulin infusion to achieve tight glycemic control (100-140mg/dL). Each study patient will be started on an insulin infusion prior to their operation. This infusion will continue throughout the operation and for 24 hours after completion of the transplant. Glucose control will then be left to the discretion of the primary team.
The control group will be treated with bolus insulin based on a standard insulin sliding scale.
Outcomes
Aim 1-
Primary endpoint- Our primary endpoint will be poor initial graft function defined by the occurrence of DGF (defined by a decrease in serum creatinine of <10%/day for 3 consecutive days after transplant) or slow graft function (serum creatinine >3 mg/dL 5 days after transplant without dialysis)
Secondary endpoint- Secondary endpoints will include wound infection, length of hospital stay, 30 day mortality, hypoglycemic episodes(glucose <70 mg/dL) and stroke.
Aim 2-
Primary endpoint- Our primary endpoints will be acute rejection at 90 days and graft survival/renal function at 3months, 6months and then yearly.
Statistical Analysis- Data will be described as means with standard deviations or percentages with ranges based on whether the data represent continuous or categorical variables. The t-test and chi-squared test will be used to test hypotheses.
- Conditions
- Diabetes, End Stage Renal Disease
- Being tested
- Insulin, Insulin, Asp(B28)-
- Keywords
- diabetes, kidney transplant, end stage renal disease, delayed draft function
- Medical subject headings
- Diabetes Mellitus, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Insulin will be given in a continuous low dose infusion. The infusion will be adjusted based on the patient's blood sugar with the goal of keeping the level between 100-140 mg/dL
Insulin, Asp(B28)-Drug
Insulin will be given through subcutaneous injection every few hours based on the patient's blood sugar level.
| Study group | Role | What they receive |
|---|---|---|
| Tight glucose control | Experimental | Patients randomized to the tight glucose control arm will be placed on an insulin infusion, or continuous low dose insulin drip. Receives: Drug: Insulin |
| Standard glucose control | Active comparator | Patients randomized to the standard glucose control group will be given subcutaneous doses of insulin every few hours based on their blood sugar. Receives: Drug: Insulin, Asp(B28)- |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Poor Graft Function After Kidney Transplant
Our primary endpoint will be poor initial graft function defined by the occurrence of DGF (defined by a decrease in serum creatinine of <10%/day for 3 consecutive days after transplant) or slow graft function (serum creatinine >3 mg/dL 5 days after transplant without dialysis)
Measured: 7 days after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014
- Study completionAug 2014
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin Parekh, MD, MAS, Principal investigator, UCSF Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643382
- Sponsor's protocol ID
- HiRT 042918
- Acronym
- HiRT
- Status last verified
- Oct 2020
- First submitted
- 16 Jul 2012
- Last updated
- 5 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Parekh J, Niemann CU, Dang K, Hirose R. Intraoperative hyperglycemia augments ischemia reperfusion injury in renal transplantation: a prospective study. J Transplant. 2011;2011:652458. doi: 10.1155/2011/652458. Epub 2011 Sep 4.
PubMed 21904663Parekh J, Bostrom A, Feng S. Diabetes mellitus: a risk factor for delayed graft function after deceased donor kidney transplantation. Am J Transplant. 2010 Feb;10(2):298-303. doi: 10.1111/j.1600-6143.2009.02936.x. Epub 2010 Jan 6.
PubMed 20055796Parekh J, Roll GR, Wisel S, Rushakoff RJ, Hirose R. Effect of moderately intense perioperative glucose control on renal allograft function: a pilot randomized controlled trial in renal transplantation. Clin Transplant. 2016 Oct;30(10):1242-1249. doi: 10.1111/ctr.12811. Epub 2016 Sep 24.
PubMed 27423055Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
PubMed 37526194Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.
PubMed 32803882
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of the Impact of Peri-operative Glucose Control on Short Term Renal Allograft Function After Transplantation
- ClinicalTrials.gov ID
- NCT01643382
- Acronym / sponsor ID
- HiRT / HiRT 042918
- Conditions
- Diabetes, End Stage Renal Disease
- Keywords
- diabetes, kidney transplant, end stage renal disease, delayed draft function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Posted 5 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Based on multiple prior studies, kidney transplant recipients with diabetes are at higher risk for poor initial graft function after transplant. Our study is designed to determine if tight blood sugar control around the time of kidney transplant will improve short term graft function.
Detailed description
Population- Our study population will include all adult diabetic patients undergoing deceased donor renal transplantation or living donor transplantation in which a swap requires transportation and resulting cold storage time. This will ensure a reasonable incidence of our primary outcome (poor short term graft function) and eliminate the potential risk of treating non-diabetic patients with insulin infusions. Patients already enrolled in a drug trial designed to study the impact of the drug on graft function will be excluded.
Study Design- This will be a randomized control trial. Recipients will be randomized to either tight peri-operative glucose control or standard management.
Methods
Randomization Protocol- In order to ensure that patients are equally distributed between groups, we will use block randomization. Blocks of 4 patients will be created with the total number of experimental versus control assignments being equal across blocks. Patients will then be randomly assigned to a block.
Interventions- The study group will be treated with an insulin infusion to achieve tight glycemic control (100-140mg/dL). Each study patient will be started on an insulin infusion prior to their operation. This infusion will continue throughout the operation and for 24 hours after completion of the transplant. Glucose control will then be left to the discretion of the primary team.
The control group will be treated with bolus insulin based on a standard insulin sliding scale.
Outcomes
Aim 1-
Primary endpoint- Our primary endpoint will be poor initial graft function defined by the occurrence of DGF (defined by a decrease in serum creatinine of <10%/day for 3 consecutive days after transplant) or slow graft function (serum creatinine >3 mg/dL 5 days after transplant without dialysis)
Secondary endpoint- Secondary endpoints will include wound infection, length of hospital stay, 30 day mortality, hypoglycemic episodes(glucose <70 mg/dL) and stroke.
Aim 2-
Primary endpoint- Our primary endpoints will be acute rejection at 90 days and graft survival/renal function at 3months, 6months and then yearly.
Statistical Analysis- Data will be described as means with standard deviations or percentages with ranges based on whether the data represent continuous or categorical variables. The t-test and chi-squared test will be used to test hypotheses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tight glucose control | Experimental | Drug: InsulinPatients randomized to the tight glucose control arm will be placed on an insulin infusion, or continuous low dose insulin drip. |
| Standard glucose control | Active comparator | Drug: Insulin, Asp(B28)-Patients randomized to the standard glucose control group will be given subcutaneous doses of insulin every few hours based on their blood sugar. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients
- diabetic
- end stage renal disease undergoing cadaveric renal transplant
Key exclusion criteria (1 listed)
- enrolled in concurrent study to test impact of a drug on graft function after transplant
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 |
|---|---|---|
| InsulinInsulin will be given in a continuous low dose infusion. The infusion will be adjusted based on the patient's blood sugar with the goal of keeping the level between 100-140 mg/dL | Drug | Tight glucose control |
| Insulin, Asp(B28)-Insulin will be given through subcutaneous injection every few hours based on the patient's blood sugar level. | Drug | Standard glucose control |
Primary outcome
Incidence of Poor Graft Function After Kidney Transplant
Time frame: 7 days after transplant
Our primary endpoint will be poor initial graft function defined by the occurrence of DGF (defined by a decrease in serum creatinine of <10%/day for 3 consecutive days after transplant) or slow graft function (serum creatinine >3 mg/dL 5 days after transplant without dialysis)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21904663Parekh J, Niemann CU, Dang K, Hirose R. Intraoperative hyperglycemia augments ischemia reperfusion injury in renal transplantation: a prospective study. J Transplant. 2011;2011:652458. doi: 10.1155/2011/652458. Epub 2011 Sep 4.
- Background: PubMed 20055796Parekh J, Bostrom A, Feng S. Diabetes mellitus: a risk factor for delayed graft function after deceased donor kidney transplantation. Am J Transplant. 2010 Feb;10(2):298-303. doi: 10.1111/j.1600-6143.2009.02936.x. Epub 2010 Jan 6.
- Results publication: PubMed 27423055Parekh J, Roll GR, Wisel S, Rushakoff RJ, Hirose R. Effect of moderately intense perioperative glucose control on renal allograft function: a pilot randomized controlled trial in renal transplantation. Clin Transplant. 2016 Oct;30(10):1242-1249. doi: 10.1111/ctr.12811. Epub 2016 Sep 24.
- Derived from this study: PubMed 37526194Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
- Derived from this study: PubMed 32803882Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.
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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.
Justin Parekh, MD, MAS principal investigator
UCSF Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin and Insulin, Asp(B28)- in people with Diabetes and End Stage Renal Disease, run by University of California, San Francisco 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 5 Nov 2020. 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 5 Nov 2020). 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?
Incidence of Poor Graft Function After Kidney Transplant (time frame: 7 days after transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01643382, which also lists 5 linked publications.
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 5 Nov 2020.