Title

A Study Comparing Outcomes of Kidney Transplants in Patients on Steroids Versus Those Who Discontinue Steroids
A Single Center, Open Label, Comparative, Controlled Trial to Assess the Risks and Benefits of Steroid Elimination vs. Steroid Therapy After Renal Transplantation
  • Phase

    Phase 4
  • Study Type

    Observational
  • Status

    Unknown status
  • Intervention/Treatment

    prednisone ...
  • Study Participants

    60
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.
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 These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids.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.
Study Started
Jan 31
2006
Study Completion
Dec 31
2008
Anticipated
Last Update
May 12
2008
Estimate

Drug prednisone

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

1 None

subjects who remain on steroids after discharge

2 None

Subjects will be off steroids at the time of discharge

Population

de novo renal transplant recipients

Criteria

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
No Results Posted