A Study Comparing Outcomes of Kidney Transplants in Patients on Steroids Versus Those Who Discontinue Steroids

Brief Summary

Official Title: “A Single Center, Open Label, Comparative, Controlled Trial to Assess the Risks and Benefits of Steroid Elimination vs. Steroid Therapy After Renal Transplantation”

The purpose of this study is to compare the risks and benefits of steroid elimination versus steroid therapy in renal transplant patients particularly looking at the effects on bone mass, lipids, hypertension, and new onset diabetes.

  • Study Type: Observational
  • Study Design: Observational Model: Case Control, Time Perspective: Prospective

Detailed Clinical Trial Description

The use of steroids after renal transplantation has been invaluable, resulting in higher rates of long term survival of the transplanted kidney. However, post-operative steroids are also associated with frequent post-operative and long term complications. There have been steroid elimination studies analyzing acute rejection rates, graft and patient survival. These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids.

With this study we will be using a rapid steroid elimination protocol for 40 patients and compare 20 patients who remain on steroids. We hope to show a decreased rate of complications such as osteopenia/osteoporosis, new onset diabetes, and a decrease in cardiovascular risk factors such as hyperlipidemia and hypertension.

Solumedrol will be given to all patients at the time of transplant followed by a prednisone taper. Those remaining on steroids will be discharged on prednisone 5 mg daily. Those in whom steroids are eliminated will be off prednisone by discharge.

Interventions Used in this Clinical Trial

  • Drug: prednisone
    • group 2 will remain on 5 mg of prednisone for at least 90 days post transplant.

Arms, Groups and Cohorts in this Clinical Trial

  • 1
    • subjects who remain on steroids after discharge
  • 2
    • Subjects will be off steroids at the time of discharge

Outcome Measures for this Clinical Trial

Primary Measures

  • Acute rejection
    • Time Frame: 6 months
      Safety Issue?: No
  • Patient and graft survival
    • Time Frame: 6 months
      Safety Issue?: No
  • Incidence of infection
    • Time Frame: one year
      Safety Issue?: No

Secondary Measures

  • Quality of life (health survey)
    • Time Frame: one year
      Safety Issue?: No
  • Incidence of post-transplant diabetes
    • Time Frame: one year
      Safety Issue?: No
  • Incidence of osteopenia/osteoporosis at baseline and one year
    • Time Frame: one year
      Safety Issue?: No
  • Renal function
    • Time Frame: one year
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Patients undergoing a single renal transplant from deceased or living donor
  • Adults 18 years and older
  • First or second renal transplant
  • Capable of understanding the purposes of the study, has given written informed consent, and agrees to comply with the study requirements
  • Women of child bearing age should have a negative serum pregnancy test

Exclusion Criteria

  • Greater than 2 renal transplants
  • Age < 18 years
  • Patients receiving immunosuppressive therapy within the preceding 28 days for first transplant and 3 months for the second transplant
  • Cold ischemia time > 30 hours
  • History of malignancy in the last 5 years except successfully treated localized non-melanoma skin cancer
  • HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) positive serology
  • Loss of previous transplant in < 1 year
  • History of non-compliance
  • Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may impair communication with the investigator or compliance with study procedures
  • Multiple organ transplant
  • History of chronic steroid use except for inhaled steroids for asthma
  • Pregnant or lactating females
  • Women of childbearing potential not willing to use a reliable form of contraception.
  • Patients with severe medical condition(s) that, in the view of the investigator, prohibits participation in the study
  • Known sensitivity to study drugs or class of study drugs
  • Use of any investigational agent in the last 30 days

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Florida Hospital Transplant Center
  • Collaborator
    • Genzyme, a Sanofi Company
  • Provider of Information About this Clinical Study
    • Michael Angelis, MD, Florida Hospital Transplant Center
  • Overall Official(s)
    • Michael Angelis, MD, Principal Investigator, Florida Hospital Transplant Center


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