Phase 4
Completed N=3
Efficacy of Belatacept in Reducing DSA
Source: ClinicalTrials.gov NCT02078193 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Change of Donor Specific Antibodies (DSA) — 35.7 percent change in DSAs
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective of this study is to demonstrate that administration of belatacept in maintenance kidney transplant recipients may cause a reduction in Donor Specific HLA Antibody (DSA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Donor Specific Antibodies (DSA) |
35.7 | — |
| SECONDARY Safety |
2 | — |
Eligibility Criteria
Inclusion Criteria
- Recipients of cadaveric, living related or living unrelated kidney transplant with positive DSA titer (two positive tests) and enrolled within 6 months of DSA detection.
- Patients with stable renal function. Stable renal function is defined as one serum creatinine (SCr) value that is +/- 10% of the baseline SCr within 3 months of enrollment (eGFR >/= 35 and /= 3 times ULN) or severe diarrhea or active peptic ulcer disease that would interfere with the appropriate conduct of the study;
- Abnormal physical or laboratory findings of clinical significance within 2 weeks of inclusion which would interfere with the objectives of the study;
- Patients with symptoms of significant somatic or mental illness or evidence of drug and/or alcohol abuse;
- Patients receiving > 10 mg/day prednisone dose;
- History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures to belatacept;
- Patients not making DSA antibodies;
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (local); females of childbearing potential who are unwilling to use effective study-approved contraceptives and who are planning to become pregnant; Sexually active fertile men must use effective birth control if their partners are women of child bearing potential;
- Any other medical condition that, in the opinion of the site investigator based on recall or chart review would interfere with completing the study, including but not limited to visual problems or cognitive impairment.
Data sourced from ClinicalTrials.gov (NCT02078193). 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.