Insulin Therapy for the Prevention of New Onset Diabetes after Transplantation - Prospective Study in Non-Diabetic De Novo Kidney Transplant Recipients

Phase 1

• Conditions: Previously non-diabetic end stage renal disease patients undergoing kidney transplantation.; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2012-000225-51-AT
• Lead Sponsor: Medizinische Universität Wien Universitätsklinik für Innere Medizin III

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-27
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

1.Adult patients with end stage renal disease undergoing kidney transplantation with a deceased or living donor kidney.
2.Absence of diabetes prior to kidney transplantation, defined according to American Diabetes Association guideline (not on oral hypoglycemic agents or insulin with fasting glucose < 126 mg/dl).
3.Receiving standard triple immunosuppressive medications that include tacrolimus, mycophenolate mofetil or mycophenolic sodium and steroids.
4.Capable of understanding the study and willing to give informed written consent for study participation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

Exclusion Criteria

1.Patients with a diagnosis of diabetes mellitus prior to kidney transplantation, or receiving anti-diabetic medications, or having pre-transplant fasting glucose level equal or greater than 126 mg/dl on two occasions at least three days apart.
2.Patients receiving an organ transplant other than kidney.
3.Patients receiving an unlicensed drug or therapy within one month prior to study entry.
4.Patients with history of hypersensitivity to injectable insulin.
5.Patients with documented HIV infection.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified