Immune Monitoring and CNI Withdrawal in Low Risk Recipients of Kidney Transplantation

Phase 2 Terminated 52 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Clinical Trials in Organ Transplantation · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The study will compare how well transplanted kidneys work and the response of people's immune systems as tacrolimus, a calcineurin inhibitor (CNI), is withdrawn. In addition, this research study will evaluate whether reducing immunosuppression can decrease some of these side effects while still preventing rejection of the kidney.

Timeline

Start: 2010-11
Primary completion: 2015-05
Completion: 2015-05

Outcome

Outcome not reported

Stopped: “Absence of equipoise on the basis of predetermined stopping rules.”

Publications

Results Hricik DE, Formica RN, Nickerson P, Rush D, Fairchild RL, Poggio ED, Gibson IW, Wiebe C, Tinckam K, Bunnapradist S, Samaniego-Picota M, Brennan DC, Schroppel B, Gaber O, Armstrong B, Ikle D, Diop H, Bridges ND, Heeger PS; Clinical Trials in Organ Transplantation-09 Consortium. Adverse Outcomes of Tacrolimus Withdrawal in Immune-Quiescent Kidney Transplant Recipients. J Am Soc Nephrol. 2015 Dec;26(12):3114-22. doi: 10.1681/ASN.2014121234. Epub 2015 Apr 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tacrolimus	Small molecule	—	—
Background	Mycophenolate Mofetil	Small molecule	—	—
Background	Prednisone	Other / unclassified	—	—
Background	rabbit anti-thymocyte globulin	Protein / enzyme biologic	—	—