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

Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00273559
• Other study ID #: TL092005-1
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 5, 2006
• Last updated: May 8, 2008
• Start date: January 2006
• Est. completion date: December 2008

Study information

• Verified date: November 2007
• Source: Florida Hospital Transplant Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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 These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids.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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Florida Hospital Transplant Center	Orlando	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Florida Hospital Transplant Center	Genzyme, a Sanofi Company, Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute rejection		6 months	No
Primary	Patient and graft survival		6 months	No
Primary	Incidence of infection		one year	No
Secondary	Quality of life (health survey)		one year	No
Secondary	Incidence of post-transplant diabetes		one year	No
Secondary	Incidence of osteopenia/osteoporosis at baseline and one year		one year	No
Secondary	Renal function		one year	No