drugset / Trial / NCT00906204
Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation
Phase 2
Completed
99 enrolled
Wright State University
Sanofi · collabThe Methodist Hospital Research Institute · collabUniversity of Arizona · collabUniversity of Nebraska · collabWake Forest University · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
In a non-blinded pilot study conducted at the University of Nebraska Medical Center, evidence was found that a single large dose of Thymoglobulin on the day of kidney transplantation produced better kidney function than the standard dosing plan, when the same amount is divided into smaller doses on 4 days. This new study repeats that dose comparison, but with double-blinding and at multiple transplantation centers.
Timeline
- Start
- 2010-03
- Primary completion
- 2014-07
- Completion
- 2014-07
Outcome
Met primary endpoint
paper Interim analysis showed primary end point noninferiority of SD-rATG induction (p = 0.6), PMID 26696251 ↗
paper we have shown SD-rATG induction to be noninferior to DD-rATG induction in early tolerability PMID 26696251 ↗
Publications
- Background Stevens RB, Mercer DF, Grant WJ, Freifeld AG, Lane JT, Groggel GC, Rigley TH, Nielsen KJ, Henning ME, Skorupa JY, Skorupa AJ, Christensen KA, Sandoz JP, Kellogg AM, Langnas AN, Wrenshall LE. Randomized trial of single-dose versus divided-dose rabbit anti-thymocyte globulin induction in renal transplantation: an interim report. Transplantation. 2008 May 27;85(10):1391-9. doi: 10.1097/TP.0b013e3181722fad.
- Background Stevens RB, Foster KW, Miles CD, Lane JT, Kalil AC, Florescu DF, Sandoz JP, Rigley TH, Nielsen KJ, Skorupa JY, Kellogg AM, Malik T, Wrenshall LE. A randomized 2x2 factorial trial, part 1: single-dose rabbit antithymocyte globulin induction may improve renal transplantation outcomes. Transplantation. 2015 Jan;99(1):197-209. doi: 10.1097/TP.0000000000000250.
- Stevens RB, Wrenshall LE, Miles CD, Farney AC, Jie T, Sandoz JP, Rigley TH, Osama Gaber A. A Double-Blind, Double-Dummy, Flexible-Design Randomized Multicenter Trial: Early Safety of Single- Versus Divided-Dose Rabbit Anti-Thymocyte Globulin Induction in Renal Transplantation. Am J Transplant. 2016 Jun;16(6):1858-67. doi: 10.1111/ajt.13659. Epub 2016 Mar 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Thymoglobulin | Protein / enzyme biologic | 1.5 mg/kg | Intravenous |
| Subject | Thymoglobulin | Protein / enzyme biologic | 6 mg/kg | Intravenous |