Phase 3
Completed N=666
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)
Chronic Kidney Disease · Chronic Kidney Failure
Source: ClinicalTrials.gov NCT00256750 ↗
Enrolled (actual)
666
Serious AEs
74.4%
Results posted
Aug 2016
Primary outcomePrimary: Percent of Participants Surviving With a Functioning Graft by Month 12 — 92.8; 96.5; 95.4 percentage of participants
◆ Published Evidence
Highly cited
761citations · ~76 / year
Belatacept and Long-Term Outcomes in Kidney Transplantation.
Summary
The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug safety will also be studied.
Linked Publications (3)
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Belatacept and Long-Term Outcomes in Kidney Transplantation.
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Three-year outcomes from BENEFIT, a randomized, active-controlled, parallel-group study in adult kidney transplant recipients.
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Beneficial effect of belatacept on health-related quality of life and perceived side effects: results from the BENEFIT and BENEFIT-EXT trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants Surviving With a Functioning Graft by Month 12 |
92.8; 96.5; 95.4 | — |
| PRIMARY Percent of Participants With a Composite of Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 or With a Decrease in mGFR Greater Than or Equal to 10 mL/Min/1.73m^2 From Month 3 to Month 12 |
77.9; 54.2; 55.0 | <.0001 sig |
| PRIMARY Percent of Participants Experiencing Acute Rejection (AR) Post-transplant by Month 12 |
7.2; 17.3; 21.9 | — |
| SECONDARY Mean Value of the Measured Glomerular Filtration Rate (mGFR) |
51.9; 61.7; 59.9; 50.4; 63.4; 65.0 | <0.0001 sig |
| SECONDARY Percent of Participants With Prevalence of Chronic Allograft Nephropathy (CAN) at Month 12 |
32.4; 23.9; 18.3 | 0.0581 |
| SECONDARY Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 |
9; 7; 7; 107; 113; 117 | — |
| SECONDARY Number of Participants With Adverse Events of Special Interest by Month 84 |
22; 16; 20; 19; 24; 20 | — |
| SECONDARY Mean Blood Pressure at Month 84 |
78.6; 75.8; 75.1; 129.0; 126.7; 126.0 | — |
| SECONDARY Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 |
26; 25; 27; 0; 1; 0 | — |
| SECONDARY Percent of Participants With Development of Anti-Donor HLA Positive Antibodies by Month 84 |
11.6; 3.1; 1.4 | — |
| SECONDARY Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24 |
-1.7; 1.2; 4.4; -2.0; 5.3; 4.2 | — |
| SECONDARY Percent of Participants With a Decrease in Measured Glomerular Filtration Rate (mGFR) Greater Than or Equal to 10mL/Min/1.73m^2 From Month 3 to Month 12 |
28.2; 23.4; 23.0 | — |
| SECONDARY Percent of Participants With a Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 |
67.6; 43; 43.5 | — |
| SECONDARY Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation |
48.8; 62.6; 62.4; 50.1; 65.4; 65.2 | — |
| SECONDARY Mean Change in Calculated Glomerular Filtration Rate (cGFR) From Month 6 to Month 12 |
2.3; 4.7; 5.1 | — |
| SECONDARY Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36 |
9.9; 4.2; 7.1; 10.5; 5.4; 8.3 | 0.0687 |
| SECONDARY Percent of Participants Using At Least One Anti-Hypertensive Medication to Control Hypertension at Month 36 |
92.9; 81.9; 83.9 | 0.0002 sig |
| SECONDARY Percent of Participants With Incidence of Hypertension Post-Transplantation at Month 12 |
75.0; 53.8; 57.1 | — |
| SECONDARY Percent of Participants With Prevalence of Hypertension Post-Transplantation at Month 12 |
91.0; 89.8; 88.6 | — |
| SECONDARY Mean Systolic Blood Pressure and Diastolic Blood Pressure |
138.7; 131.4; 132.7; 81.9; 78.7; 79.3 | — |
| SECONDARY Percent of Participants at Baseline With Controlled Hypertension Post Transplantation by Month 12 |
21.4; 28.6; 24.6 | — |
| SECONDARY Percent of Participants With Prevalence of Controlled Hypertension at Month 12 |
21.0; 28.0; 24.7 | — |
| SECONDARY Percent of Non-dyslipidemic Participants With Incidence of Dyslipidemia Post-Transplantation by Month 12 |
80.0; 63.8; 70.9 | — |
| SECONDARY Percent of Participants With Prevalence of Dyslipidemia at Month 12 |
52.9; 44.7; 46.1 | — |
| SECONDARY Percent of Participants With Controlled Dyslipidemia at Month 12 |
18.1; 15.5; 15.5 | — |
| SECONDARY Number of Participants With Antihyperlipidemic Medication by Intensity Level |
17; 15; 17; 46; 27; 39 | — |
| SECONDARY Percent of Participants Using At Least One Anti-Hyperlipidemic Medication |
56.6; 46.2; 47.9 | — |
| SECONDARY Mean Value of Lipid Parameters |
144.1; 131.5; 131.7; 191.5; 182.4; 181.3 | — |
| SECONDARY Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36 |
5.4; 16.8; 21.9; 9.0; 17.3; 24.2 | — |
| SECONDARY Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 |
1; 4; 7; 5; 9; 3 | — |
| SECONDARY Percent of Participants Using Polyclonal Antilymphocyte Preparations for Impaired Renal Function and Anticipated Delayed Graft Function by Month 12 |
3.6; 0.4; 0.5 | — |
| SECONDARY Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 |
0.5; 4.4; 5.9; 0.9; 4.4; 5.9 | — |
| SECONDARY Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 |
0.0; 4.0; 5.9; 0.0; 5.3; 6.4 | — |
| SECONDARY Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12 |
13; 29; 39; 13; 34; 43 | — |
| SECONDARY Percent of Participants With Subclinical Rejection at Month 12 |
5.2; 4.7; 4.3 | — |
| SECONDARY Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 |
43; 68; 70; 56; 72; 75 | — |
| SECONDARY Mean Value of Physical and Mental Components Using SF-36 Questionnaire |
49.4; 49.9; 51.1; 47.3; 48.9; 49.2 | 0.6573 |
| SECONDARY Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire |
50.6; 52.5; 52.7; 47.9; 48.2; 49.0 | 0.0714 |
| SECONDARY Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) |
0.4643; 0.4407; 0.4451; 0.4721; 0.4495; 0.4459 | <0.0001 sig |
| SECONDARY Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 |
5.4; 6.2; 7.3; 5.0; 6.2; 6.7 | 0.4498 |
| SECONDARY Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 |
2.9; 4.5; 4.6; 6.7; 7.1; 7.3 | — |
| SECONDARY Percent of Participants Surviving With a Functioning Graft |
90.5; 94.7; 94.1; 88.7; 92.0; 92.2 | — |
| SECONDARY Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36 |
13.6; 19.5; 25.1; 18.1; 19.9; 27.9 | — |
Eligibility Criteria
Inclusion Criteria
- The subject is a recipient of a living donor or deceased donor kidney transplant.
- Male or Female, 18 or older
Exclusion Criteria
- First time recipient, PRA >- 50% or for retransplantation PRA >- 30%.
- If retransplantation, previous graft loss cannot be due to acute rejection.
- Positive cross match.
- Subject receiving extended criteria donor (ECD) organ
- For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)
Data sourced from ClinicalTrials.gov (NCT00256750) and the linked publication. 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.