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A Two Part, Phase 1/2, Safety, PK and PD Study of TOL101, an Anti-TCR Monoclonal Antibody for Prophylaxis of Acute Organ Rejection in Patients Receiving Renal Transplantation


Phase 1/Phase 2
18 Years
60 Years
Open (Enrolling)
Both
End Stage Renal Disease, Renal Transplant

Thank you

Trial Information

A Two Part, Phase 1/2, Safety, PK and PD Study of TOL101, an Anti-TCR Monoclonal Antibody for Prophylaxis of Acute Organ Rejection in Patients Receiving Renal Transplantation


Inclusion Criteria:



- Recipient of a primary renal transplant from a living or standard criteria cadaveric
donor

- Male or female 18-60 years of age

- Recipient with a PRA < 20%

Exclusion Criteria:

- Previous solid organ transplant

- Recipient of HLA-identical kidney allograft transplant

- Recipient of an ABO incompatible donor kidney

- Known HIV infection or other major infection

- History of malignancy within 3 years (excluding treated basal cell or squamous cell
carcinoma of the skin) prior to enrollment

- History of tuberculosis

- Recipient with cardiovascular disease

- Treatment with immunosuppressive medications within 1 month prior to enrollment

- Known or suspected allergy to mice

- Pregnant or lactating

- Unable or unwilling to participate in all required study activities for the duration
of the study (6 months)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety and tolerability of ascending doses of TOL101 and the effectiveness of TOL101 to target and downregulate T cells in patients undergoing first renal transplantation

Outcome Description:

The following safety parameters will be monitored: Adverse events, standard laboratory safety evaluations (hematology and serum chemistries), symptom constellation indicating cytokine release syndrome, serum concentrations of cytokines and nitric oxide, malignancies, CMV viremia, BKV viremia, EBV viremia and other infections

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Stuart Flechner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Food and Drug Administration

Study ID:

TTI-121

NCT ID:

NCT01154387

Start Date:

July 2010

Completion Date:

June 2013

Related Keywords:

  • End Stage Renal Disease
  • Renal Transplant
  • Kidney
  • Renal
  • Transplant
  • Kidney Transplant
  • Kidney Failure
  • Induction
  • Monoclonal
  • Antibody
  • T cell
  • Anti-rejection
  • Immunosuppression
  • Kidney Diseases
  • Kidney Failure, Chronic

Name

Location
University of Michigan Ann Arbor, Michigan  48109-0624
Cleveland Clinic Foundation Cleveland, Ohio  44195
Medical University of South Carolina Charleston, South Carolina  29425-0721
Montefiore Medical Center Bronx, New York  10467-2490
Baylor University Medical Center Dallas, Texas  75246
University of Utah Salt Lake City, Utah  
University of Kentucky Lexington, Kentucky  40536-0098
St Barnabas Medical Center Livingston, New Jersey  07039
University of Colorado Denver Denver, Colorado  80262
University of Virginia Health System Charlottesville, Virginia  22903
Buffalo General Hospital Buffalo, New York  14209
Baylor All Saints Fort Worth, Texas  76104