NCT02108600

Tocilizumab for Renal Graft Inflammation

A Phase II Trial of the Efficacy and Safety of Tocilizumab for Treatment of Inflammation in the Renal Allograft

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Flavio Vincenti · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Randomized open label clinical trial in which 48 renal transplant recipients with inflammation in the 6 month allograft biopsy will either continue usual immunosuppression or receive monthly Actemra (Tocilizumab) infusions for 6 months in addition to usual immunosuppression.

Detailed description

This is a prospective randomized controlled study of kidney transplant recipients with SCI on 6-month surveillance kidney biopsies. SCI for the purpose of this study is defined as 10-50% total parenchymal mononuclear inflammation (Banff ti1-ti2) with \<i2,t2 concurrent lesions. After enrollment, study participants subjects will be randomized to group 1 (standard of care group) or group 2 (tocilizumab (TCZ) group). Block randomization will be performed by the UCSF investigational pharmacy using computer-generated random numbers. The pathologist will be blinded to the randomization. Group 1 (standard of care group) will continue their usual immunosuppression and not receive any specific intervention. Group 2 (TCZ group) will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses.In addition, they will continue their usual immunosuppressive regimen. As noted above, both groups will continue their usual maintenance immunosuppression regimen. Therefore, recipients who are already receiving prednisone will continue it at 5 mg/day. Recipients on prednisone-free regimens will remain prednisone-free. Mycophenolate mofetil will be continued at the same dose as at the time of the biopsy. Tacrolimus dosing will be adjusted to aim for trough levels of 5-8 mcg/L. The study period will be 12 months (6 months of therapy plus 6 months of extended follow up- see Study Schema). Any episodes of infections, renal allograft dysfunctions, rejections or other clinical events during the study period will be treated per the usual standard of care. All participants will be seen by the study PI or co-investigator at monthly study visits. A focused history and physical exam will be performed, including queries for drug toxicities and signs/ symptom of infections. All participants will obtain laboratory tests at intervals of 4 weeks, consisting of a complete blood count, serum electrolytes, BUN and serum creatinine, fasting glucose, liver function tests and 12-hour trough tacrolimus levels. Lipid panels will be obtained at baseline, then every 12 weeks an at study termination.The outpatient electronic medical record will be queried twiceweekly by the study coordinator for any new laboratory results on study participants. Laboratory data on all study participants will be reviewed weekly by the study PI. The 12-month surveillance biopsy will be performed at the end of therapy (6 months after study enrollment).

Conditions

• Late Complication From Kidney Transplant

Interventions

Type	Name	Description
DRUG	Tocilizumab	Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.

Timeline

• Start date: 2014-06-01
• Primary completion: 2018-12-16
• Completion: 2018-12-16
• First posted: 2014-04-09
• Last updated: 2021-03-09
• Results posted: 2021-01-27

Locations

1 site across 1 country: United States