Clinical trial NCT00273559: A Study Comparing Outcomes of Kidney Transplants in Patients on Steroids Versus Those Who Discontinue Steroids
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Diseases
Keywords: Renal Transplantation
Lead sponsor: Florida Hospital Transplant Center
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
name: Novartis
First posted: 2006-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: de novo renal transplant recipients

Brief 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.

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 These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids.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

Primary outcomes:
measure: Acute rejection
timeFrame: 6 months
measure: Patient and graft survival
timeFrame: 6 months
measure: Incidence of infection
timeFrame: one year
Secondary outcomes:
measure: Quality of life (health survey)
timeFrame: one year
measure: Incidence of post-transplant diabetes
timeFrame: one year
measure: Incidence of osteopenia/osteoporosis at baseline and one year
timeFrame: one year
measure: Renal function
timeFrame: one year
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital Transplant Center
state: Florida
Study officials:
affiliation: Florida Hospital Transplant Center
name: Michael Angelis, MD
role: PRINCIPAL_INVESTIGATOR
References: