The ONE Study nTreg Trial (ONEnTreg13)

Phase 1

Completed

• Conditions: Immunosuppressive Treatment of Living-donor Renal Transplantation
• Interventions: Biological: autologous CD4+CD25+FoxP3+ natural regulat. T cells (nTregs)

• Registration Number: NCT02371434
• Lead Sponsor: Prof. Dr. Petra Reinke

Brief Summary

The aim of this trial is to collect evidence of the safety of administering autologous CD4+CD25+FoxP3+ natural regulatory T cells (nTregs) to living-donor renal transplant recipients. In addition, the study will determine whether post-transplant nTregs infusion allows a tapering of conventional maintenance immunosuppression within 60 weeks after transplantation.

Detailed Description

The ONE Study aims to explore the feasibility, safety and efficacy of regulatory cell therapies as adjunct immunosuppressive treatments in the context of living-donor renal transplantation.The clinical trial presented here (ONEnTreg13) will test autologous, polyclonally expanded CD4+CD25+FoxP3+ nTregs as a somatic cell-based medicinal product.

The objective of this study is to determine whether administration of nTregs to recipients of living-donor kidney transplants is safe and able to polarize the immunological response of the recipient away from graft rejection and towards graft acceptance, allowing a reduction in the doses of pharmacological maintenance immunosuppression.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-18
• Study First Submitted QC: 2015-02-19
• Study First Posted: 2015-02-25
• Primary Completion: 2017-11-01
• Study Completion: 2017-11-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	autologous CD4+CD25+FoxP3+ natural regulat. T cells (nTregs)	Patients in ONEnTreg13 will be treated with four immunosuppressive agents, all of which are classified as an Investigational Medicinal Products (IMPs): * nTregs * Prednisolone * MMF * Tacrolimus

Primary Outcome Measures

Name	Time	Method
Incidence of biopsy-confirmed acute rejection (BCAR) within 60 weeks of organ transplantation	60 weeks
Incidence of infectious complications associated with cell administration.	60 weeks
Incidence of embolic pulmonary complications and other embolic events.	60 weeks
Incidence of immune responses resulting in anaphylactic reactions, cardiovascular compromise or other acute organ failure.	60 weeks
Biochemical disturbances associated with the cell infusion.	60 weeks
Over-suppression of the immune system assessed by the incidence of opportunistic infections, especially, CMV, EBV and polyoma virus.	60 weeks
Over-suppression of the immune system assessed by the incidence of neoplasia.	60 weeks

Secondary Outcome Measures

Name	Time	Method
Prevention of acute rejection will be secondarily assessed by measuring	60 weeks	i) time to first acute rejection episode ii) severity of acute rejection episodes based on response to treatment and histological scoring iii) the level of total immunosuppression drugs at the final trial visit.
Incidence of patients treated for subclinical acute rejection on the basis of histopathological findings	60 weeks
Prevention of chronic graft dysfunction (chronic rejection or IF/TA) will be assessed by clinical (impairment of GFR) and histopathological (Banff staging) measures.	60 weeks
Incidence of post-transplant dialysis, inclusion on the transplant waiting list or retransplantation following graft loss through rejection (acute or chronic).	60 weeks
Avoidance of drug-related complications by immunosuppressant reduction will be assessed by the incidence of reported adverse drug reactions.	60 weeks

Trial Locations

Locations (1)

Charité University Medicine, Dept. of Nephrology and Internal Intensive Care; 🇩🇪 Berlin, Germany