Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant
Condition: Transplants and Implants
Intervention: prednisone; rabbit antithymocyte globulin; Tacrolimus; Prednisone; Mycophenolate mofetil; Mycophenolate mofetil
Intervention description: In this group, participants had prednisone rapidly decreased until completely eliminated by day 6 after transplant. Participants began on 500mg of intravenous methylprednisolone on the day of transplant, followed by the following doses of oral prednisone: 160mg on day 1, 120mg on day 2, 80mg on day 3, 40mg on day 4, 20mg on day 5, none from day 6-on.; Participants in both groups received 3 to 5 doses of an intravenous medication to prevent rejection called Thymoglobulin (rabbit antithymocyte globulin) as per our standard of care. This drug was dosed at 1.5 milligrams/killograms per dose and dosing was then based on body weight. The dose was decreased in half or held if the participant had a low white blood cell count or if the participant a low platelet count. The first dose was given intravenously in the operating room and subsequent intravenous doses were administered either while participants were inpatients or outpatients for a total of 3 to 5 doses for a total of up to 6mg/kg. The number of doses was based on transplant kidney function and risk factors for rejection.; Participants in both groups received tacrolimus per our standard of care. This medication helped to prevent rejection and was initially dosed at 0.1-0.2 milligrams/killograms/day in two divided doses, given orally, based on participant's body weight. We then looked at the trough levels of this medication(the lowest level before the next dose), and aimed to keep the trough level between 5-10 nanograms/milliliter throughout the study.; Participants in this group continued on prednisone indefinitely. Participants began with 500mg of intravenous methylprednisolone on the day of transplant, followed by the following doses of oral prednisone: 160mg on day 1, 120mg on day 2, 80mg on day 3, 40mg on day 4, 20 mg days 5-9, 15 mg day 10-19, 10 mg day 20-24, 7.5 mg day 25-29, and 5mg from day 30-on indefinitely.; Participants in both groups received mycophenolate mofetil by mouth twice daily indefinitely. Dosing for patients in the Prednisone withdrawal group was 1000mg orally twice daily. The dose was decreased or held at the discretion of the physician, for side effects such as low white blood cell count, or low platelet count, or if the participant experienced stomach side effects such as heartburn, nausea, vomiting or diarrhea.; Participants in both groups received mycophenolate mofetil by mouth twice daily indefinitely. Dosing for patients in the Prednisone maintenance group was 500 mg orally twice daily. The dose was decreased or held at the discretion of the physician, for side effects such as low white blood cell count, or low platelet count, or if the participant experienced stomach side effects such as heartburn, nausea, vomiting or diarrhea.
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Tacrolimus; Thymoglobulin; Antilymphocyte Serum
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 19 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: kidney transplantation; tacrolimus; Prograf; mycophenolate mofetil; CellCept; corticosteroid withdrawal; prednisone withdrawal; prednisone maintenance; rabbit antithymocyte globulin; Thymoglobulin

Summary:

      The purpose of the study was to determine if rapid discontinuation of corticosteroids (also
      known as prednisone withdrawal) and maintenance immunosuppression with Prograf (tacrolimus)
      and CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte
      globulin) will give similar safety and efficacy results compared to continuation of
      corticosteroids (also known as prednisone maintenance) and standard maintenance
      immunosuppression with Prograf (tacrolimus), CellCept (mycophenolate mofetil) while using
      Thymoglobulin (Rabbit antithymocyte globulin).
    

Eligibility criteria:

        Inclusion Criteria:

          -  First time kidney transplant recipients who receives a kidney from a cadaveric, living
             related or living unrelated donor

          -  Age greater than 18 years and less than 75 years

          -  Caucasian recipients

          -  Patients with current low panel reactive antibody (PRA) levels (<10%)

          -  Patients with signed and dated informed consent

          -  Women of childbearing potential must have a negative pregnancy test at baseline and
             agree to use a medically acceptable method of contraception throughout the treatment
             period.

        Exclusion Criteria:

          -  Other than Caucasian ethnicity

          -  Patients with HIV+ or

          -  Patients with HbsAg+ or Hepatitis C positive

          -  Patients with a history of malignancy in the past 5 years

          -  Patients with active systemic or localized major infection

          -  Patients with a history of chronic steroid use for other diseases