A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients

Astellas

Status and phase: Completed; Phase 2

Conditions: Kidney Transplantation

Treatments: Drug: tacrolimus; Drug: mycophenolate mofetil; Drug: Corticosteroids; Drug: basiliximab; Drug: Alefacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00543569

0485-CL-U201

Details and patient eligibility

About

A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.

Full description

This is a 4 arm (all active) study to determine the safety and efficacy of Alefacept in de novo kidney transplant recipients.

Enrollment: 323 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is anticipated to receive first oral dose of tacrolimus within 48 hours of transplant procedure
• Subject is a recipient of a de novo kidney transplant
• Subject is a recipient of a kidney from a non-human leukocyte antigen (HLA) identical related living donor, a non-related living donor, or a deceased donor

Exclusion criteria

• Subject has a screening (pre-operative)estimated cluster of differentiation (CD) 4+ T-cell count of < 250 cells/µL

• Subject will receive a kidney with an anticipated cold ischemia time (CIT) of > 30 hours

• Recipient has a positive T or B-cell cross match by investigational site's standard method of determination

• Subject will receive a kidney from a 50-65 year old deceased donor with one of the following:

  • History of hypertension and a terminal serum creatinine > 1.5 mg/dL
  • Cerebrovascular accident as cause of death and a terminal serum creatinine > 1.5 mg/dL
  • History of hypertension and cerebrovascular accident as cause of death and a terminal serum creatinine > 1.5 mg/dL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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323 participants in 4 patient groups

Tacrolimus/MMF/Basiliximab

Active Comparator group

Description:

Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.

Treatment:

Drug: basiliximab

Drug: mycophenolate mofetil

Drug: Corticosteroids

Drug: tacrolimus

Alefacept QW/Tacrolimus/MMF

Experimental group

Description:

Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.

Treatment:

Drug: Alefacept

Drug: mycophenolate mofetil

Drug: Corticosteroids

Drug: tacrolimus

Alefacept QW/Tacrolimus

Experimental group

Description:

Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.

Treatment:

Drug: Alefacept

Drug: Corticosteroids

Drug: tacrolimus

Alefacept QOW/Tacrolimus/MMF

Experimental group

Description:

Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.

Treatment:

Drug: Alefacept

Drug: mycophenolate mofetil

Drug: Corticosteroids

Drug: tacrolimus