Trial Outcomes & Findings for Immunosuppression Impact on the Metabolic Control of Kidney Transplant With Pre-Existing Type 2 Diabetes (DM) (NCT NCT00296296)

NCT ID: NCT00296296

Last Updated: 2017-10-06

Results Overview

The count of participants with freedom from insulin therapy post transplant is reported.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 29 participants
• Primary outcome timeframe: From hospital discharge to 1 year post-transplant
• Results posted on: 2017-10-06

Participant Flow

Participant milestones

Measure	Cyclosporin Patients receive cyclosporin (Neoral; dose-adjusted to pre-established targets) as immunosuppressive calcineurin inhibitor (CNI) and Diabetes Education / Management (therapeutic adjustment to target American Diabetes Association (ADA) criteria)	Tacrolimus Patients receive tacrolimus (Prograf; dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
Overall Study STARTED	11	18
Overall Study COMPLETED	9	5
Overall Study NOT COMPLETED	2	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunosuppression Impact on the Metabolic Control of Kidney Transplant With Pre-Existing Type 2 Diabetes (DM)

Baseline characteristics by cohort

Measure	Cyclosporin n=11 Participants Patients receive cyclosporin (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)	Tacrolimus n=18 Participants Patients receive tacrolimus (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)	Total n=29 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	8 Participants n=5 Participants	16 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	16 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: From hospital discharge to 1 year post-transplant

The count of participants with freedom from insulin therapy post transplant is reported.

Outcome measures

Measure	Cyclosporin n=11 Participants Patients receive cyclosporin (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)	Tacrolimus n=18 Participants Patients receive tacrolimus (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
Freedom From Insulin Therapy Post Transplant	3 Participants	4 Participants

PRIMARY outcome

Timeframe: 1 year post-transplantation

Values of ≥60 ml/min/1.73 m^2 are considered optimal; ≥30-59 ml/min/1.73 m^2 are indicative of successful graft function; lower values are indicative or graft dysfunction.

Outcome measures

Measure	Cyclosporin n=11 Participants Patients receive cyclosporin (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)	Tacrolimus n=18 Participants Patients receive tacrolimus (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
Estimated Glomerular Filtration Rate (eGFR) 1 Year Following Transplantation ≥60 ml/min/1.73 m^2	4 Participants	6 Participants
Estimated Glomerular Filtration Rate (eGFR) 1 Year Following Transplantation ≥30-59 ml/min/1.73 m^2	6 Participants	9 Participants
Estimated Glomerular Filtration Rate (eGFR) 1 Year Following Transplantation <30 ml/min/1.73 m^2	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 1 year post-transplantation

Count of participants alive at one year post transplantation

Outcome measures

Measure	Cyclosporin n=11 Participants Patients receive cyclosporin (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)	Tacrolimus n=18 Participants Patients receive tacrolimus (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
Patient Survival at One Year Post Transplantation	10 Participants	16 Participants

SECONDARY outcome

Timeframe: 1 year post-transplantation

Outcome measures

Measure	Cyclosporin n=11 Participants Patients receive cyclosporin (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)	Tacrolimus n=18 Participants Patients receive tacrolimus (dose-adjusted to pre-established targets) as CNI and Diabetes Education / Management (therapeutic adjustment to target ADA criteria)
Count of Participants With Biopsy Proven Acute Rejection at One Year Post Transplantation	1 Participants	3 Participants

Adverse Events

Cyclosporin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tacrolimus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephan Busque, MD

Stanford University

Phone: 650-498-6189

Email: sbsuque@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place