Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04955366 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Abatacept Conversion in Kidney Transplantation

StatusCompleted
PhasePhase 2
Started2021-09-22
View on ClinicalTrials.gov ↗

Amendment history

2026-09-17
Trial completed
2025-10-09
Study Status v6
Re-verified, no change to tracked fields
2024-09-25
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations, IPDSharing v5
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-10→2026-06
Completion date2024-10→2026-06
Enrollment targetestimated 86→confirmed 87
Study sitesdetails revised at 1 of 1 site
2023-09-07
Study Status, Eligibility v4
Eligibility criteria-75 characters
[...] al transplant recipients of either living donor or deceased donors:donor Treatment with belatacept from the time of transplant At le [...] c risk First time transplant HLA antibody screen with PRA < 5080% against class I and class II antigens Negative crossmatch [...] study) GFR less than 35 Serum creatinine at enrollment more than30than 30% higher than at 3 months (±4 weeks) prior to randomization HbA1C greater than 8%within 3 months of enrollment (diabetic patients only) Recent history of clinically significant proteinuria (urinar [...] mg po QD (or mycophenolic acid or azathioprine equivalent). - Receiving pre [...] [...]
2022-09-29
Study Status, Arms and Interventions, Eligibility v3
Eligibility criteria+145 characters
[...] hioprine (1-2 mg/kg daily) dose, and prednisone 5 mg daily. Confirmed Tb screening at the time of transplantation Exclusion Criteria: Individuals who meet any of these criter [...] dy adherence and follow up. History of medical noncompliance Untreated latent Tb (as determined from prior Tb screening at the time of transplantation)
Show 2 earlier versions
2021-09-23
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-08→confirmed 2021-09-22
Secondary endpoints16 entries, revised
Number of deathdeaths at 6, 12 and 24 months post baseline
Study sitesdetails revised at 1 of 1 site
2021-07-20
Study Status v1
Start date2021-07→2021-08
2021-07-06
Original filing
This is a single center, randomized, controlled phase 2b, conversion trial. This protocol has been developed to answer the question: Can patients be safely converted from monthly belatacept IV infusions to abatacept subcutaneous injections without a decrease in kidney function.The primary objective will be the difference in estimated GFR (eGFR) for abatacept and belatacept groups using a monthly repeated measures model between randomization and 12 months.
Trial Details
NCT Number NCT04955366
Lead Sponsor Emory University
Conditions Renal Transplant Recipient
Enrollment 87 participants
Start Date 2021-09-22
Primary Completion 2026-06-10 (estimated)
Study Completion 2026-06-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-16