BMT and High Dose Post-Transplant Cyclophosphamide for Chimerism Induction and Renal Allograft Tolerance

NCT02029638 ↗

Phase 2 Terminated 4 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network (ITN) · collab

NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to assess the ability of bone marrow transplantation (BMT) and high-dose post-transplantation cyclophosphamide (PT/Cy) to induce renal allograft tolerance and thus enable discontinuation of immunosuppressive therapy in haploidentical living related donor renal transplant recipients.

Timeline

Start: 2014-01-07
Primary completion: 2017-09-06
Completion: 2017-09-06

Publications

Background Solez K, Colvin RB, Racusen LC, Haas M, Sis B, Mengel M, Halloran PF, Baldwin W, Banfi G, Collins AB, Cosio F, David DS, Drachenberg C, Einecke G, Fogo AB, Gibson IW, Glotz D, Iskandar SS, Kraus E, Lerut E, Mannon RB, Mihatsch M, Nankivell BJ, Nickeleit V, Papadimitriou JC, Randhawa P, Regele H, Renaudin K, Roberts I, Seron D, Smith RN, Valente M. Banff 07 classification of renal allograft pathology: updates and future directions. Am J Transplant. 2008 Apr;8(4):753-60. doi: 10.1111/j.1600-6143.2008.02159.x. Epub 2008 Feb 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclophosphamide	Other / unclassified	50 mg/kg	Intravenous
Background	2-MERCAPTOETHANESULFONIC ACID	Small molecule	—	—
Background	ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE)	Protein / enzyme biologic	2 mg/kg	Intravenous
Background	Acetaminophen	Small molecule	650 mg	Oral
Background	Diphenhydramine	Unknown	25 mg	Oral
Background	Fludarabine	Small molecule	30 mg/m2	Intravenous
Background	Methylprednisolone	Other / unclassified	0.25 mg/kg	Intravenous
Background	Mycophenolate Mofetil	Small molecule	1 g	Oral
Background	Prednisone	Other / unclassified	5 mg	Oral
Background	filgrastim	Protein / enzyme biologic	5 ug/kg	Subcutaneous

Indications

No indication recorded.