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

May 8, 2008 updated by: Florida Hospital Transplant Center

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids.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.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Florida Hospital Transplant Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

de novo renal transplant recipients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
subjects who remain on steroids after discharge
2
Subjects will be off steroids at the time of discharge
Drug: prednisone
group 2 will remain on 5 mg of prednisone for at least 90 days post transplant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute rejection
Time Frame: 6 months
6 months
Patient and graft survival
Time Frame: 6 months
6 months
Incidence of infection
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life (health survey)
Time Frame: one year
one year
Incidence of post-transplant diabetes
Time Frame: one year
one year
Incidence of osteopenia/osteoporosis at baseline and one year
Time Frame: one year
one year
Renal function
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida Hospital Transplant Center

Collaborators

Novartis
Genzyme, a Sanofi Company

Investigators

  • Principal Investigator: Michael Angelis, MD, Florida Hospital Transplant Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

January 5, 2006

First Submitted That Met QC Criteria

January 5, 2006

First Posted (Estimate)

January 9, 2006

Study Record Updates

Last Update Posted (Estimate)

May 12, 2008

Last Update Submitted That Met QC Criteria

May 8, 2008

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TL092005-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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