TRIAL OF STEROID AVOIDANCE AND LOW-DOSE CNI BY ATG-INDUCTION IN RENAL TRANSPLANTATIO

Phase 1

• Conditions: kidney transplantation; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2012-000451-13-DK
• Lead Sponsor: Per Lindner

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-27
• Last Update Posted: 15 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Patients receiving a first or second single kidney transplant from a deceased or a living donor.
2.Female or male aged above 18 years.
3.Patients considered for a standard immunosuppressive protocol.
4.Patients capable of giving written informed consent for participation in the study for 24 months.

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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.Patients with known diabetes mellitus or plasma glucose >11.1 mmol/l at admission
2.Patients receiving steroids at the time of transplantation or likely to need steroids after transplantation
3.Recipients of multiorgan transplants, and or previously transplanted with any other organ than kidney
4.Patients with CDC-PRA > 25 % in most recent test or for any other reason considered to be of a high risk for rejection which requires an enhanced immunosuppression.
5.Patients receiving a renal transplant from a HLA-identical sibling
6.Patients with hypersensitivity to, or other reasons to not be able to take the immunosuppressive drugs used in the study
7.Patients who are recipients of ABO-incompatible transplants
8.Patients who are unlikely to comply with the study requirements
9.Patients, and/or those receiving organs from donors, who are positive for HIV, Hepatitis B surface antigen or Hepatitis C virus.
10.Females of childbearing potential, who are, or are planning to be, pregnant, and/or are unwilling to use effective means of contraception.

Study & Design

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