Phase 2
Completed N=218
A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients
De Novo Kidney Transplantation
Source: ClinicalTrials.gov NCT00617604 ↗
Enrolled (actual)
218
Serious AEs
56.1%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection at Month 6 Assessed by Local Review — 6.7; 10.6 percentage of participants
Summary
The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection at Month 6 Assessed by Local Review |
6.7; 10.6 | — |
| SECONDARY Percentage of Participants With Biopsy Confirmed Antibody-Mediated Acute Rejection at Month 6 |
2.9; 3.8 | — |
| SECONDARY Percentage of Participants With Biopsy Confirmed Acute Rejection (T-Cell Mediated or Antibody Mediated) at Month 6 |
9.3; 12.4 | — |
| SECONDARY Percentage of Participants With Biopsy Confirmed Acute Mixed T-Cell Mediated and Antibody-Mediated Rejection at Month 6 |
0.0; 1.0 | — |
| SECONDARY Percentage of Participants With Acute Rejection Diagnosed by Signs and Symptoms at Month 6 |
27.4; 22.3 | — |
| SECONDARY Percentage of Participants With Clinically Treated Acute Rejection at Month 6 |
24.8; 15.4 | — |
| SECONDARY Percentage of Participants With Steroid-resistant Acute Rejection at Month 6 |
7.6; 5.7 | — |
| SECONDARY Percentage of Participants With Biopsy-Confirmed Acute T-cell Mediated Rejection as Assessed by Central Review at Month 6 |
9.6; 7.7 | — |
| SECONDARY Patient Survival |
97.1; 99.0 | — |
| SECONDARY Graft Survival |
90.6; 95.2 | — |
| SECONDARY Maximum Histological Grade of All Biopsies After Local Review |
93.5; 89.5; 2.8; 1.9; 0.0; 1.0 | — |
| SECONDARY Percentage of Participants With Anti-Lymphocyte Antibody Therapy for Treatment of Rejection at Month 6 |
4.7; 6.7 | — |
| SECONDARY Change From Month 1 in Serum Creatinine |
-5.0125; -5.0830; -6.1777; -11.7212 | — |
| SECONDARY Change From Month 1 in Glomerular Filtration Rate (GFR) |
3.1548; 0.2889; 2.4275; 2.5444 | — |
| SECONDARY Change From Month 1 in Creatinine Clearance |
3.0336; -0.5849; 4.5388; 3.0227 | — |
| SECONDARY GFR Measured by Iothalamate Clearance at Month 6 |
59.6029; 55.1613 | — |
| SECONDARY Percentage of Participants With Efficacy Failure at Month 6 |
15.0; 21.0 | — |
| SECONDARY Percentage of Participants With Delayed Graft Function |
12.1; 7.6 | — |
| SECONDARY Percentage of Participants With Treatment Failure at Month 6 |
20.6; 25.7 | — |
| SECONDARY Number of Participants With Adverse Events |
102; 101; 36; 41; 56; 56 | — |
Eligibility Criteria
Inclusion Criteria
- Subject with end stage kidney disease who is a suitable candidate for primary kidney transplantation or retransplantation
- Male or female subject at least 18 years of age and younger than 65 years
- Subject receiving a kidney transplant from a non-human leucocyte antigen (HLA) identical living donor or deceased HLA identical/non-HLA identical donor between 5 and 59 years of age with compatible ABO blood type (Blood group system A, B, AB and 0)
Exclusion Criteria
- Subject has a panel reactivity antibody grade > 20% in the previous 6 months and/or had had a previous graft survival shorter than 1 year due to immunological reasons
- Subject received a kidney transplant from a non-heart beating donor
- Subject has received a kidney transplant from a 50 - 59 year old donor with two of the following three factors: history of hypertension, cerebrovascular accident as cause of death, final pre-procurement serum creatinine > 1.5 mg/dL (united network for organ sharing [UNOS] expanded criteria donor)
- Cold ischemia time of the donor kidney is ≥ 30 hours
Data sourced from ClinicalTrials.gov (NCT00617604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.