Trial of Steroid Avoidance and Low-dose CNI by ATG-induction in Renal Transplantation

NCT ID: NCT02083991

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2017-12-31

Brief Summary

Balancing immunosuppressive treatment in organ transplantation in order to achieve effective prevention of rejection on one side and avoidance of negative side effects on the other side is a major challenge, leading to developing different immunosuppressive protocols. Cornerstones of immunosuppressive treatment such as Corticosteroids (CS) and Calcineurin Inhibitors (CNI) are known to cause an increased incidence of diabetes, cardiovascular morbidity, nephrotoxicity and malignancies.

The investigators believe that both avoidance of CS and minimization of CNI, while using Anti-ThymocyteGlobuline(ATG) induction (instead of interleucin-2 receptor blockers) and mycofenolate mofetil(MMF) therapeutic drug monitoring is going to reduce negative side effects, without increased rejection frequency in renal transplanted patients.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Steroid-free low TAC-arm

Induction therapy: Thymoglobulin i.v. 2,5 mg/kg day 0 and 1, preceded by methylprednisolone i.v. 250 mg day 0 and 50 mg day 1.

Maintenance therapy: Advagraf(TAC) 0,2 mg/kg p.o. started day1 (target concentration 5-10 ng/ml, after 3 months 4-7 ng/ml; MMF 1g x 2 p.o. (target Area Under Curve, AUC 40-60 mg.h/L); No steroids p.o.

Group Type: EXPERIMENTAL

Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolon

Intervention Type: DRUG

Standard low-TAC arm

Induction therapy: Simulect i.v. 20 mg day 0 and 4; Steroids i.v. according to local practice.

Maintenance therapy: Advagraf(TAC) p.o. 0,2 mg/(target concentration 5-10 ng/ml, after 3 months 4-7 ng/ml); MMF 1g x 2 p.o. (target AUC 40-60 mg.h/L); Steroids p.o. according to hospital practice (but not less than 5mg daily after 6 months).

Group Type: ACTIVE_COMPARATOR

Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolon

Intervention Type: DRUG

Interventions

Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolon

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• First or second single kidney (cadaveric or living donors) transplant recipients.
• Considered for a standard immunosuppressive protocol.
• Must be capable of giving written informed connect for participation in the study for 24 months.

Exclusion Criteria

• Diabetes mellitus or plasma glucose >11,1 at admission.
• Receiving steroids at the time of transplantation or likely to need steroids after transplantation.
• Multiorgan transplants and/or previously transplanted with any other organ than kidney.
• Panel reacting antibodies(PRA) >25% in most recent test or considered to be of high risk for rejection which requires an enhanced immunosuppression.
• Renal transplants from HLA-identical sibling.
• Hypersensitivity to, or disability to take immunosuppressive drugs.
• Blood group(ABO)-incompatible transplants.
• Unlikely to comply with the study requirements.
• Transplant from donor positive for HIV, HBsAg, Hepatitis C.
• Female of childbearing potential planing/being pregnant or unwilling to use contraception.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per Lindnér, MD

Role: PRINCIPAL_INVESTIGATOR

Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden

Locations

Transplant Institute, Sahlgrenska University Hospital

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

2012-000451-13

Identifier Type: -

Identifier Source: org_study_id