Trial Outcomes & Findings for The Differential Effects of 3 Different Immunosuppressive (NCT NCT00729248)

Results Overview

CD4+CD25 high FOXP3+ cell levels in mixed lymphocyte reactions (MLRs) of Renal Pre-transplant Recipients/Donors were measured in the presence of 1) No Drug/Control; 2) 0.05-0.2, 0.3-3 and \> 5 ng/ml Tacrolimus (TAC); OR 3) 0.05-0.2, 0.3-3 and \> 5 ng/ml Sirolimus (SRL). CD4+CD25 high FOXP3+ cell levels in the MLRs with TAC or SRL are expressed as the percentage of CD4+CD25 high FOXP3+ cell levels in the MLRs with no drug.

Recruitment status

COMPLETED

Target enrollment

12 participants

Primary outcome timeframe

3 months

Results posted on

2013-08-28

Participant Flow

Recruit donor/recipient renal transplant subjects for blood draw before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combinations: Recipient PMBC + Donor PBMC + No drug Recipient PMBC + Donor PBMC + Tacrolimus (TAC) Recipient PMBC + Donor PBMC + Sirolimus (SRL)

Participant milestones

Participant milestones
Measure	Participants 12 participants were recruited/consented for the study. 2 subjects (donor/recipient pair) were withdrawn from the study. Ten participants (5 donors, 5 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination: Recipient PMBC + Donor PBMC + Sirolimus (SRL)
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants 12 participants were recruited/consented for the study. 2 subjects (donor/recipient pair) were withdrawn from the study. Ten participants (5 donors, 5 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination: Recipient PMBC + Donor PBMC + Sirolimus (SRL)
Overall Study Physician Decision	2

Baseline Characteristics

The Differential Effects of 3 Different Immunosuppressive

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=12 Participants All participants (6 donors, 6 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination: Recipient PMBC + Donor PBMC + No drug Recipient PMBC + Donor PBMC + Tacrolimus (TAC) Recipient PMBC + Donor PBMC + Sirolimus (SRL)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age Continuous	47.08 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: For each arm, blood samples from 5 donor/recipient pairs (i.e., 10 participants) were used.

CD4+CD25 high FOXP3+ cell levels in mixed lymphocyte reactions (MLRs) of Renal Pre-transplant Recipients/Donors were measured in the presence of 1) No Drug/Control; 2) 0.05-0.2, 0.3-3 and \> 5 ng/ml Tacrolimus (TAC); OR 3) 0.05-0.2, 0.3-3 and \> 5 ng/ml Sirolimus (SRL). CD4+CD25 high FOXP3+ cell levels in the MLRs with TAC or SRL are expressed as the percentage of CD4+CD25 high FOXP3+ cell levels in the MLRs with no drug.

Outcome measures

Outcome measures
Measure	MLRs in the Presence of TAC n=10 Participants All participants (5 donors, 5 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination: REcipient PMBC + Donor PBMC + Tacrolimus (TAC)	MLRs in the Presence of SRL n=10 Participants All participants (5 donors, 5 recipietns) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in teh following combination: Recipient PMBC + Donor PBMC + Sirolimus (SRL)
CD4+CD25 High FOXP3+ Cell Levels in Mixed Lymphocyte Reactions (MLRs) of Renal Pre-transplant Recipients/Donors Cell Levels in 0.05-0.2 ng/mL TAC or SRL	90 Percentage of Control Cells Standard Deviation 20	85 Percentage of Control Cells Standard Deviation 5
CD4+CD25 High FOXP3+ Cell Levels in Mixed Lymphocyte Reactions (MLRs) of Renal Pre-transplant Recipients/Donors Cell Levels in 0.3-3 ng/mL TAC or SRL	25 Percentage of Control Cells Standard Deviation 15	50 Percentage of Control Cells Standard Deviation 10
CD4+CD25 High FOXP3+ Cell Levels in Mixed Lymphocyte Reactions (MLRs) of Renal Pre-transplant Recipients/Donors Cell Levels in > 5 ng/mL TAC or SRL	10 Percentage of Control Cells Standard Deviation 5	45 Percentage of Control Cells Standard Deviation 10

Adverse Events

All Participants

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

Lorenzo Gallon, MD - Study Principal Investigator

Northwestern University

Phone: 312-695-4457

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place