Trial Outcomes & Findings for Prospective Pilot Study of Pre-Transplant Thymoglobulin Administration in Living Donor Renal Transplant Recipients (NCT NCT00771745)

NCT ID: NCT00771745

Last Updated: 2016-01-18

Results Overview

Proportion of Patients Meeting the Composite End Point of Acute Rejection, Graft loss or Patient death

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 11 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2016-01-18

Participant Flow

Participant milestones

Measure	Preloading Induction With Thymoglobulin Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF	Preloading Induction With Thymoglobulin® X 3 Doses Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF
Overall Study STARTED	6	5
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prospective Pilot Study of Pre-Transplant Thymoglobulin Administration in Living Donor Renal Transplant Recipients

Baseline characteristics by cohort

Measure	Preloading Induction With Thymoglobulin n=6 Participants Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF	Preloading Induction With Thymoglobulin® X 3 Doses n=5 Participants Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF	Total n=11 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	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	50.1 years STANDARD_DEVIATION 17.1 • n=5 Participants	36.1 years STANDARD_DEVIATION 12.5 • n=7 Participants	43.1 years STANDARD_DEVIATION 17.1 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Patients received tacrolimus (goal level 10-15 ng/mL) and mycophenolate mofetil (2gm daily) at time of transplant. Methylprednisolone (MP), acetaminophen, and diphenhydramine were given as premedication for each rATG dose (500mg MP 1st dose, 250mg MP subsequent 2 doses, 125mg MP 4th dose).

Proportion of Patients Meeting the Composite End Point of Acute Rejection, Graft loss or Patient death

Outcome measures

Measure	Preloading Induction With Thymoglobulin x 4 Doses n=6 Participants Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF	Preloading Induction With Thymoglobulin® X 3 Doses n=5 Participants Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF
Composite End Point of Acute Rejection, Graft Loss or Patient Death Patient Death	0 participants	0 participants
Composite End Point of Acute Rejection, Graft Loss or Patient Death Acute rejection	1 participants	1 participants
Composite End Point of Acute Rejection, Graft Loss or Patient Death Graft Loss	0 participants	0 participants

SECONDARY outcome

Timeframe: Ongoing

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Not defined

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Not defined

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Not defined

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post-operative days 1-7, 30, 90 and 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Undefined

Outcome measures

Outcome data not reported

Adverse Events

Preloading Induction With Thymoglobulin

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Preloading Induction With Thymoglobulin® X 3 Doses

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Preloading Induction With Thymoglobulin n=6 participants at risk Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF	Preloading Induction With Thymoglobulin® X 3 Doses n=5 participants at risk Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF
Renal and urinary disorders Banff 1A Rejection	16.7% 1/6 • Number of events 1	0.00% 0/5
Renal and urinary disorders Renal Allograft Dysfunction	16.7% 1/6 • Number of events 1	0.00% 0/5
Renal and urinary disorders Acute Renal Failure / Anemia	0.00% 0/6	20.0% 1/5 • Number of events 2
Renal and urinary disorders Fever/Acute Renal Failure/Acidosis	0.00% 0/6	20.0% 1/5 • Number of events 3
Renal and urinary disorders Increased Serum Creatinine	0.00% 0/6	20.0% 1/5 • Number of events 1

Other adverse events

Measure	Preloading Induction With Thymoglobulin n=6 participants at risk Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF	Preloading Induction With Thymoglobulin® X 3 Doses n=5 participants at risk Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF
Immune system disorders Fever / Chills	66.7% 4/6 • Number of events 4	60.0% 3/5 • Number of events 3
Vascular disorders Hypertension	16.7% 1/6 • Number of events 1	20.0% 1/5 • Number of events 1
Immune system disorders Fever > 102°F	16.7% 1/6 • Number of events 1	20.0% 1/5 • Number of events 1
General disorders Body Aches	16.7% 1/6 • Number of events 1	20.0% 1/5 • Number of events 1
Gastrointestinal disorders Nausea/Vomiting	0.00% 0/6	20.0% 1/5 • Number of events 1
Investigations PLT < 100,000 cells/mm3	16.7% 1/6 • Number of events 1	20.0% 1/5 • Number of events 1

Additional Information

Dr. Rita Alloway

University of Cincinnati

Phone: 513-558-1568

Email: Rita.Alloway@uc.edu

Results disclosure agreements

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