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

Phase 4

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT02083991
• Lead Sponsor: Vastra Gotaland Region

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-11
• Primary Completion: 2017-01
• Study Completion: 2017-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-03
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of New Onset of Diabetes After Transplantation(NODAT)	12 month after transplantation

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of NODAT	3, 6, 24 month after transplantation
Incidence of hypertension	3, 12, 24 months	Standardized measurement.
Cumulative frequency of infections	10 days, 3, 6, 12, 24 months	Collecting AE reports
Composite measure	12, 24 months	Freedom from acute rejection, graft and patient survival
Antihypertensive treatment	3, 12, 24 months	Number and type of antihypertensive drugs.
Incidence of acute rejection and chronic changes	12 months	Analysed by protocol biopsies, evaluated by the Banff system.
Lipid lowering drugs	12, 24 months	Number and type of lipid lowering drugs.
Incidence of antibody-mediated rejection	12, 24 months	Analysed by biopsies, evaluated by the Banff system, and by donor-specific HLA antibodies
Cumulative frequency of cardiovascular complications and events.	10 days, 3, 12, 24 months	Collecting Adverse Events (AE) reports
Cumulative frequency of malignancy.	6, 12, 24 months	Collecting AE reports
Renal function	12, 24 months	Evaluated by measured glomerular filtration rate (mGFR)

Trial Locations

Locations (1)

Transplant Institute, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden