NCT02083991

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for phase_4 diabetes-mellitus

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_4 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

4 years

First QC Date

March 3, 2014

Last Update Submit

January 3, 2021

Conditions

Diabetes Mellitus

Keywords

NODATRenal transplantationCorticosteroids avoidanceCNI minimization

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of New Onset of Diabetes After Transplantation(NODAT)

    12 month after transplantation

Secondary Outcomes (11)

  • Cumulative incidence of NODAT

    3, 6, 24 month after transplantation

  • Composite measure

    12, 24 months

  • Renal function

    12, 24 months

  • Incidence of acute rejection and chronic changes

    12 months

  • Incidence of hypertension

    3, 12, 24 months

  • +6 more secondary outcomes

Study Arms (2)

Steroid-free low TAC-arm

EXPERIMENTAL

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.

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

Standard low-TAC arm

ACTIVE COMPARATOR

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).

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

Interventions

Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolonDRUG
Standard low-TAC armSteroid-free low TAC-arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Transplant Institute, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Per Lindnér, MD

    Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 11, 2014

Study Start

January 1, 2013

Primary Completion

January 1, 2017

Study Completion

December 1, 2017

Last Updated

January 5, 2021

Record last verified: 2021-01

Locations

SE(1)