A Phase 1/2 interventional study of Anti-Thymocyte Globulin and TOL101 in End Stage Renal Disease and Renal Transplant, sponsored by Tolera Therapeutics, Inc. Status unknown at 12 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-06-11.
Sponsored by Tolera Therapeutics, Inc · Phase 1/2, Interventional, and Treatment
Induction therapy with antibodies is administered during transplant surgery and for a short period of time following transplant surgery in an effort to render the immune system less able to mount an initial rejection response. In general, induction therapy is associated with better outcomes compared to the absence of induction therapy. However, currently used induction agents, some of which are not labeled or indicated for induction therapy in transplantation, have drawbacks related to long-term immune system suppression increasing susceptibility to opportunistic infections or malignancies, and other immune-mediated side effects.
An unmet medical need exists for a more specific approach to prevent acute organ rejection, without unnecessarily exposing the patient to non-specific or open-ended immune suppression, which may exacerbate the risks of infections and malignancies. TOL101 is a novel antibody that targets a very specific immune cell type that is critical in the acute organ rejection response. In this two-part study, TOL101 will be evaluated for the prophylaxis of acute organ rejection when used as part of an immunosuppressive regimen that includes steroids, MMF, and tacrolimus in first time kidney transplant recipients.
This study will test the hypothesis that a more specific approach (with TOL101) to prevention of acute organ rejection may provide similar or better efficacy than the currently used induction antibodies (such as Anti-Thymocyte Globulin or Thymoglobulin) while carrying fewer risks in terms of opportunistic infections, malignancies and adverse effects.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's planned enrollment of 85 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →This is the only study on the registry with Tolera Therapeutics, Inc as lead sponsor.
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Exclusion Criteria:
Anti-Thymocyte Globulin induction as part of an immunosuppressive regimen that includes steroids, MMF, and tacrolimus.
Drug: Anti-Thymocyte Globulin · Drug: Steroids · Drug: Tacrolimus · Drug: Mycophenolate mofetil (MMF)
TOL101 induction as part of an immunosuppressive regimen that includes steroids, MMF, and tacrolimus.
Drug: TOL101 · Drug: Steroids · Drug: Tacrolimus · Drug: Mycophenolate mofetil (MMF)
TOL101 induction as part of an immunosuppressive regimen that includes steroids, MMF, and tacrolimus.
Drug: TOL101 · Drug: Steroids · Drug: Tacrolimus · Drug: Mycophenolate mofetil (MMF)
1.5mg/kg IV on Day of Transplant and 1.0-1.5 mg/kg IV once daily for a minimum of 4.5mg/kg and a maximum of 7.5mg/kg total cumulative dose
Also known as: Thymoglobulin
Potential Therapeutic Dose (PTD)-A (0.28-56 mg to be determined in Phase 1/Part A ) IV once daily x 6-10 doses starting on Day of Transplant
Potential Therapeutic Dose (PTD)-B (0.28-56 mg to be determined in Phase 1/Part A ) IV once daily x 6-10 doses starting on Day of Transplant
IV methylprednisolone prior to first 3 doses of study drug; oral prednisone tapered to 5-10 mg over 6 months
Oral administration started by 6 days post-transplantation and continued for 6 months
Oral administration started by Day 1 post-transplantation and continued for 6 months
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
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
Time frame: 6 months
The effects of ascending doses of TOL101 on CD3+ T lymphocyte numbers and other immune cell subsets
Time frame: 14 days post-transplant (Part A); 6 months (Part B)
The pharmacokinetic (PK) profile of TOL101 in renal transplant recipients and the exposure-response (PK parameter to CD3+ T lymphocyte numbers) relationship over time
Time frame: 14 days post-transplant
Biopsy-proven acute organ rejection
Time frame: 6 months
Graft survival
Time frame: 6 months
Patient survival
Time frame: 6 months
Renal function by measured GFR at 6 months post-transplant and urine protein to creatinine ratio at 3 and 6 months post-transplant
Time frame: 6 months
Delayed graft function
Time frame: first 7 days post-transplant
Immunogenicity of TOL101 by measurement of anti-TOL101 antibodies
Time frame: at 14 and 28 days post-transplant
The presence of Donor Specific Antibody at 3 months (Part B only) and 6 months post-transplant
Time frame: 6 months
This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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