A prospective randomized study of corticosteroid withdrawal in low-risk kidney transplant recipient selected by immune monitoring method

A prospective randomized study to compare incidence of acute rejection and graft/patient survival between prednisolone ( or methylprednisolone) withdrawal 3 months after transplant and maintaining with Tacrobell and Myfortic in low-risk kidney transplant recipient selected by immune monitoring method

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000664

Enrollment

236

Registered

2013-02-05

Start date

2008-09-03

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Initially, all patients receive basiliximab induction, tacrolimus, myfortic acid, and prednisolone. At 12 weeks after kidney transplant, the patients who met the criteria (no rejection before 1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Primary live donor transplant patients aged 18 to 65 years 2.Either female patients of child bearing potential with negative pregnancy test and agreed to practice birth control while receiving or male patients 3.Patients must be willing and able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1.Deceased donor transplant patients 2.Patients who have HLA identical live donor 3.Patients who have current PRA > 50%. 4.Patients who are recipients of or schedulled for non-renal transplants. 5.Patients with known positive results of the following serological tests: HIV-1 Ab, HbsAg, or anti-HCV ab. 6.Patients with evidence of active infection. 7.Patients with a history of malignancies. 8.Patients who have congestive heart failure (Ejection fraction < 35%)

Design outcomes

Primary

Measure	Time frame
Biopsy-proven acute rejection	—

Secondary

Measure	Time frame
Patient survival;Graft survival	—

Countries

Korea, Republic of

Contacts

Public ContactWooseong Huh

Samsung Medical Center

Outcome results