Phase 2
Completed N=323
A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients
Source: ClinicalTrials.gov NCT00543569 ↗Enrolled (actual)
323
Serious AEs
56.3%
Results posted
Dec 2015
Primary outcomePrimary: Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review — 12.7; 26.3; 18.8; 16.7 percentage of participants
Summary
A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review |
12.7; 26.3; 18.8; 16.7 | — |
| SECONDARY Patient Survival at Month 6 and Month 12 |
96.2; 94.8; 97.3; 93.6; 87.3; 92.2 | — |
| SECONDARY Graft Survival at Month 6 and Month 12 |
96.2; 93.5; 96.0; 92.3; 87.3; 90.9 | — |
| SECONDARY Percentage of Participants With BCAR at Month 12 Assessed by Local Review |
15.4; 29.0; 20.2; 18.1 | — |
| SECONDARY Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review |
7.7; 18.3; 12.1; 14.2; 7.7; 19.7 | — |
| SECONDARY Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review |
12.7; 25.0; 18.8; 16.7; 14.0; 27.7 | — |
| SECONDARY Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review |
7.7; 17.0; 12.1; 14.2; 7.7; 18.4 | — |
| SECONDARY Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12 |
54.7; 59.3; 51.6; 58.0; 5.7; 3.2 | — |
| SECONDARY Change From Week 4 in GFR by Iothalamate Clearance at Month 6 |
48.00; 56.51; 44.36; 52.09; 5.81; 3.47 | — |
| SECONDARY Change From Week 4 in Serum Creatinine at Month 6 and 12 |
1.5; 1.6; 1.6; 1.5; -0.0; -0.2 | — |
| SECONDARY Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review |
15.2; 29.9; 22.7; 23.1; 25.3; 33.8 | — |
| SECONDARY Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review |
11.4; 22.1; 16.0; 20.5; 19.0; 26.0 | — |
| SECONDARY Time to First BCAR Assessed by Local Review |
9; 12; 19; 12.5 | — |
| SECONDARY Time to First BCAR Assessed by Central Review |
19; 10; 12; 11.5 | — |
| SECONDARY Time to First T-cell Mediated BCAR Assessed by Local Review |
9; 12; 18; 12.5 | — |
| SECONDARY Time to First T-cell Mediated BCAR Assessed by Central Review |
19; 10; 12; 11.5 | — |
| SECONDARY Maximum Grade of T-cell Mediated Rejection Assessed by Local Review |
4; 6; 8; 2; 3; 4 | — |
| SECONDARY Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review |
1; 1; 2; 1; 0; 3 | — |
| SECONDARY Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12 |
19.0; 33.8; 29.3; 23.1; 20.3; 35.1 | — |
| SECONDARY Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12 |
6.3; 20.8; 12.0; 7.7; 6.3; 20.8 | — |
| SECONDARY Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12 |
1.3; 3.9; 4.0; 2.6; 1.3; 7.8 | — |
| SECONDARY Percentage of Participants With Treatment Failure at Month 6 and 12 |
26.6; 37.7; 38.4; 29.5; 35.5; 45.5 | — |
| SECONDARY Gastrointestinal Quality of Life Index Score Over Time |
2.85; 2.97; 3.00; 2.98; 2.96; 3.29 | — |
| SECONDARY Gastrointestinal Symptom Rating Scale Scores Over Time |
1.72; 1.43; 1.59; 1.48; 1.52; 1.42 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00543569). 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.