Research Study of ATG and Rituximab in Renal Transplantation

Conditions

• Renal Transplant Recipients

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• ATG — DRUG
  1.5 mg/kg IV infusion on day of transplant, and 3 additional on days 2 through 7 after transplant.
• Rituximab — DRUG
  375 mg/m\^2 IV infusion on day -6 before transplant and on day 1 after transplant.
• Tacrolimus — DRUG
  Taken orally. Tacrolimus dose adjusted to maintain target blood levels of 6-10 ng/mL.
• Sirolimus — DRUG
  Taken orally. Initial dose, 2 mg daily on day 10 post-transplant, subsequently adjusted to achieve trough levels of 8-12 ng/mL through week 56. Sirolimus withdrawal will be initiated between week 56 and week 88 in eligible participants.
• MMF — DRUG
  1 g twice daily on days 0 through 12

Study Details

The purpose of this study is see if a combination of two drugs, (ATG and rituximab), given at the time of the transplant surgery, will help reduce or eliminate the need for long term immunosuppressive medication.

Key Dates

Start date

Jul 25, 2011

Status verified

Nov 2018

Primary completion

Jun 17, 2016

Completion

Aug 25, 2017

Study Design

Enrollment

10 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Induction (Rituximab and ATG)
  Study participants will undergo induction with rituximab and ATG and an initial maintenance therapy with tacrolimus, mycophenolate mofetil (MMF) and sirolimus. MMF will be discontinued on day 12. Participants will be evaluated for eligibility for tacrolimus withdrawal which must be initiated between weeks 26 and 38. Tacrolimus withdrawal must be completed in no fewer than 4 weeks and no more than 8 weeks. Then after at least 26 weeks on sirolimus monotherapy, participants will be evaluated for eligibility for sirolimus withdrawal which must be initiated between weeks 56 and 88. Sirolimus withdrawal must be completed in no fewer than 12 weeks and no more than 26 weeks.

Primary Outcome Measure

Percent of Participants Successfully Withdrawn From Immunosuppression and Remained Off Immunosuppression for at Least 52 Weeks [ Time Frame: Transplantation through 52 weeks after discontinuation of all immunosuppression ]

Locations (6)

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