Trial Outcomes & Findings for Hyperglycemia in Renal Transplantation (NCT NCT01643382)

Last Updated: 2020-11-05

Results Overview

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)

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

7 days after transplant

Results posted on

2020-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	Tight Glucose Control Patients randomized to the tight glucose control arm will be placed on an insulin infusion, or continuous low dose insulin drip. Insulin: 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	Standard Glucose Control Patients randomized to the standard glucose control group will be given subcutaneous doses of insulin every few hours based on their blood sugar. Insulin, Asp(B28)-: Insulin will be given through subcutaneous injection every few hours based on the patient's blood sugar level.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hyperglycemia in Renal Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tight Glucose Control n=30 Participants Patients randomized to the tight glucose control arm will be placed on an insulin infusion, or continuous low dose insulin drip. Insulin: 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	Standard Glucose Control n=30 Participants Patients randomized to the standard glucose control group will be given subcutaneous doses of insulin every few hours based on their blood sugar. Insulin, Asp(B28)-: Insulin will be given through subcutaneous injection every few hours based on the patient's blood sugar level.	Total n=60 Participants Total of all reporting groups
Age, Continuous	60.9 years STANDARD_DEVIATION 9.1 • n=5 Participants	60.7 years STANDARD_DEVIATION 11 • n=7 Participants	60.8 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Islander	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Duration dialysis	5.9 years STANDARD_DEVIATION 2.6 • n=5 Participants	5.7 years STANDARD_DEVIATION 2.7 • n=7 Participants	5.8 years STANDARD_DEVIATION 3.7 • n=5 Participants
Duration diabetes	18.6 years STANDARD_DEVIATION 11 • n=5 Participants	21.1 years STANDARD_DEVIATION 9.9 • n=7 Participants	19.9 years STANDARD_DEVIATION 14.2 • n=5 Participants
Hemoglobin A1C	6.5 percent hemoglobin STANDARD_DEVIATION 1.2 • n=5 Participants	6.7 percent hemoglobin STANDARD_DEVIATION 1 • n=7 Participants	6.6 percent hemoglobin STANDARD_DEVIATION 1.6 • n=5 Participants
Preoperative diabetic regimen Insulin	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Preoperative diabetic regimen Oral	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Preoperative diabetic regimen None	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days after transplant

Outcome measures

Outcome measures
Measure	Tight Glucose Control n=30 Participants Patients randomized to the tight glucose control arm will be placed on an insulin infusion, or continuous low dose insulin drip. Insulin: 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	Standard Glucose Control n=30 Participants Patients randomized to the standard glucose control group will be given subcutaneous doses of insulin every few hours based on their blood sugar. Insulin, Asp(B28)-: Insulin will be given through subcutaneous injection every few hours based on the patient's blood sugar level.
Incidence of Poor Graft Function After Kidney Transplant	13 Participants	22 Participants

Adverse Events

Tight Glucose Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Glucose Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Justin Parekh, MD, MAS

University of California, San Francisco

Phone: 415-595-3707

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place