NCT01921218 (IM103-133) is a Phase 3 clinical trial of Belatacept in Failing Renal Allograft, sponsored by Andrew B Adams.

Who is sponsoring NCT01921218?

NCT01921218 is sponsored by Andrew B Adams.

What drugs are being tested in NCT01921218?

Interventions in NCT01921218: Belatacept, Calcineurin inhibitor therapy, Mycophenolate mofetil, prednisone.

What condition does NCT01921218 study?

NCT01921218 studies Failing Renal Allograft.

Is NCT01921218 still recruiting?

NCT01921218 is currently completed. Last updated 6 January 2021.

Are results published for NCT01921218?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-01-06 · How we verify

NCT01921218: IM103-133

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Belatacept Therapy for the Failing Renal Allograft

Completed Phase 3 Results posted Last updated 6 January 2021

What this trial tests

Phase 3 trial testing Belatacept in Failing Renal Allograft in 13 participants. Completed in 12 December 2019.

Timeline

1 August 2013

Primary endpoint
12 December 2019

12 December 2019

Quick facts

Lead sponsor	Andrew B Adams
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	1 August 2013
Primary completion	12 December 2019
Estimated completion	12 December 2019
Sites	1 location across United States

Drugs / interventions tested

Belatacept (BELATACEPT) — full drug profile →
Calcineurin inhibitor therapy — full drug profile →
Mycophenolate mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →
prednisone (prednisone) — full drug profile →

Conditions studied

Failing Renal Allograft — all drugs for Failing Renal Allograft →

Sponsor

Andrew B Adams — full company profile →

Who can join

Adults 18 to 70, any sex, with Failing Renal Allograft. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Participants With Donor-specific Antibody Formation
Time frame: Month 36
The number of participants in each group with donor-specific antibody formation at 36 months following randomization.

Sponsor's own description

The purpose of this study is to test the safety and effectiveness of belatacept (Nulojix®) in preventing antibody formation in patients with chronic failing kidney transplants. This study is a randomized study of first-time kidney transplant patients who have worsening kidney function and biopsy proven grade 2 or 3 interstitial fibrosis/tubular atrophy (IF/TA). Patients must be eligible to get a second transplant. They must have completed or be actively undergoing evaluation for re-listing for a second transplant. Patients will be randomized to either convert to belatacept or continue on calcineurin inhibitor-based therapy.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Managing Patients with Failing Kidney Allograft: Many Questions Remain.
Davis S, Mohan S. · · 2022 · cited 44× · PMID 33692118 · DOI 10.2215/cjn.14620920
The past, present, and future of costimulation blockade in organ transplantation.
Schroder PM, Fitch ZW, Schmitz R, Choi AY, et al · · 2019 · cited 43× · PMID 31157670 · DOI 10.1097/mot.0000000000000656

Verify or expand the search:

Other trials of Belatacept

Trials testing the same drug.

NCT06918990 — Treatment of Antibody-Mediated Rejection (ABMR) With CarBel · Phase 2 · not yet recruiting
NCT06291077 — Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BEL · Phase 4 · not yet recruiting
NCT06478017 — Belatacept in Heart Transplantation · Phase 2 · recruiting
NCT06055608 — Advancing Transplantation Outcomes in Children · Phase 2 · recruiting
NCT06307808 — Viral Immunity in Solid Organ Transplant Recipients: Monitoring Of The Response To Hepatitis B Booster Vaccination · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01921218 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Andrew B Adams
Last refreshed: 6 January 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01921218.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing