Trial Outcomes & Findings for A Safety Study of Tocilizumab to Improve Transplant Rates in Highly Sensitized Patients Awaiting Kidney Transplantation (NCT NCT01594424)

Last Updated: 2016-08-25

Results Overview

patients will be in the study for up to 2 years

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

24 months

Results posted on

2016-08-25

Participant milestones
Measure	IVIG + Tocilizumab (TCZ) All patients received IVIg 10% (2.0 g/kg \[maximum 140 g per dose\] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Withdrawal data not reported

A Safety Study of Tocilizumab to Improve Transplant Rates in Highly Sensitized Patients Awaiting Kidney Transplantation

Baseline characteristics by cohort
Measure	IVIG + Tocilizumab (TCZ) n=10 Participants All patients received IVIg 10% (2.0 g/kg \[maximum 140 g per dose\] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
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	0 Participants n=5 Participants
Age, Continuous	48 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

Timeframe: 24 months

patients will be in the study for up to 2 years

Outcome measures
Measure	IVIG + Tocilizumab (TCZ) n=10 Participants All patients received IVIg 10% (2.0 g/kg \[maximum 140 g per dose\] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
Number of Participants With Serious Infectious Complications Following Transplantation	2 participants

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events
Measure	IVIG + Tocilizumab n=10 participants at risk All patients received IVIg 10% (2.0 g/kg \[maximum 140 g per dose\] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
Infections and infestations Pneumonia	10.0% 1/10 • Number of events 1
Renal and urinary disorders Hyperkalemia	10.0% 1/10 • Number of events 1
Gastrointestinal disorders Infective colitis with colonic perforation	10.0% 1/10 • Number of events 1
Infections and infestations Bells Palsy	10.0% 1/10 • Number of events 1

Other adverse events
Measure	IVIG + Tocilizumab n=10 participants at risk All patients received IVIg 10% (2.0 g/kg \[maximum 140 g per dose\] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
Gastrointestinal disorders Nausea	10.0% 1/10 • Number of events 1
Musculoskeletal and connective tissue disorders abdominal pain	10.0% 1/10 • Number of events 1
General disorders Headache	10.0% 1/10 • Number of events 1
Musculoskeletal and connective tissue disorders Itching	10.0% 1/10 • Number of events 1
Eye disorders Blurred Vision	10.0% 1/10 • Number of events 1
Blood and lymphatic system disorders Anemia	10.0% 1/10 • Number of events 1
Blood and lymphatic system disorders thrombocytopenia	10.0% 1/10 • Number of events 1
Hepatobiliary disorders elevated liver function enzymes	30.0% 3/10 • Number of events 3
Cardiac disorders Elevated blood pressure	10.0% 1/10 • Number of events 1
General disorders Minimal infusion related reaction	10.0% 1/10 • Number of events 1

Cedars-Sinai Medical Center, Comprehensive Transplant Center

Phone: 310-248-8186