A Study Comparing Outcomes of Kidney Transplants in Patients on Steroids Versus Those Who Discontinue Steroids - Full Text View

Sponsors and Collaborators:	Florida Hospital Transplant Center Genzyme Novartis
Information provided by:	Florida Hospital Transplant Center
ClinicalTrials.gov Identifier:	NCT00273559

Purpose

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.

Condition	Intervention	Phase
Kidney Diseases	Drug: prednisone	Phase IV

Study Type:	Observational
Study Design:	Case Control, Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Prednisone

U.S. FDA Resources

Further study details as provided by Florida Hospital Transplant Center:

Primary Outcome Measures:

Acute rejection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Patient and graft survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Incidence of infection [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life (health survey) [ Time Frame: one year ] [ Designated as safety issue: No ]
Incidence of post-transplant diabetes [ Time Frame: one year ] [ Designated as safety issue: No ]
Incidence of osteopenia/osteoporosis at baseline and one year [ Time Frame: one year ] [ Designated as safety issue: No ]
Renal function [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2008

Groups/Cohorts	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273559

Locations

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

Sponsors and Collaborators

Florida Hospital Transplant Center

Genzyme

Novartis

Investigators

Principal Investigator:

Michael Angelis, MD

Florida Hospital Transplant Center

More Information

No publications provided

Responsible Party:	Florida Hospital Transplant Center ( Michael Angelis, MD )
Study ID Numbers:	TL092005-1
Study First Received:	January 5, 2006
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00273559 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Florida Hospital Transplant Center:

Renal Transplantation

Study placed in the following topic categories:

Anti-Inflammatory Agents
Prednisone
Antineoplastic Agents, Hormonal
Urologic Diseases
Hormone Antagonists

Hormones, Hormone Substitutes, and Hormone Antagonists
Kidney Diseases
Hormones
Glucocorticoids

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Antineoplastic Agents, Hormonal
Urologic Diseases
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Kidney Diseases
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2009