Effects of Inhibiting Early Inflammation in Kidney Transplant Patients
Summary
During transplant surgery, there is a period of time when a donated kidney is removed from a donor's body and stored until the time of the transplant surgery. The storage procedure results in buildup of various proteins within the kidney that can injure the donated kidney after it is transplanted. One of these proteins is tumor necrosis factor-alpha (TNF-alpha). The purpose of this study is to evaluate whether taking infliximab, which blocks tumor necrosis factor alpha (TNF-alpha), just prior to transplant surgery, along with usual transplant medicines will protect the donated kidney from damage caused by TNF-alpha and help keep the transplanted kidney healthy for a longer period of time.
Timeline
- Start
- 2015-11-02
- Primary completion
- 2021-07-23
- Completion
- 2021-07-23
Outcome
Missed primary endpoint
registry analysis (superiority test); Experimental vs Control; p = 0.099; Mean Difference (Final Values) -4.90 (95% CI -10.73 to 0.93); Mixed Models Analysis NCT02495077 ↗
paper There was no difference in the primary end point of 24-month eGFR PMID 36195441 ↗
Publications
- Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
- Hricik DE, Armstrong B, Alhamad T, Brennan DC, Bromberg JS, Bunnapradist S, Chandran S, Fairchild RL, Foley DP, Formica R, Gibson IW, Kesler K, Kim SJ, Mannon RB, Menon MC, Newell KA, Nickerson P, Odim J, Poggio ED, Sung R, Shapiro R, Tinckam K, Vincenti F, Heeger PS. Infliximab Induction Lacks Efficacy and Increases BK Virus Infection in Deceased Donor Kidney Transplant Recipients: Results of the CTOT-19 Trial. J Am Soc Nephrol. 2023 Jan 1;34(1):145-159. doi: 10.1681/ASN.2022040454. Epub 2022 Oct 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Infliximab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Background | Acetaminophen | Small molecule | 600 mg | Oral |
| Background | Acetaminophen | Small molecule | 1000 mg | Oral |
| Background | Diphenhydramine | Small molecule | 25 mg | Oral |
| Background | Diphenhydramine | Small molecule | 50 mg | Oral |
| Background | Loratadine | Small molecule | 10 mg | Oral |
| Background | Methylprednisolone | Other / unclassified | 500 mg | — |
| Background | Mycophenolate Mofetil | Small molecule | 2000 mg | — |
| Background | Prednisone | Other / unclassified | 5 mg | — |
| Background | Prednisone | Other / unclassified | 10 mg | — |
| Background | Tacrolimus | Small molecule | 0.1 mg/kg | — |
| Background | Thymoglobulin | Protein / enzyme biologic | 4.5 mg/kg | — |
| Background | Thymoglobulin | Protein / enzyme biologic | 6 mg/kg | — |
Indications
No indication recorded.