|
Steroid Withdrawal in Pediatric Kidney Transplant Recipients Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Steroid Withdrawal in Pediatric Kidney Transplant Recipients conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Steroid Withdrawal in Pediatric Kidney Transplant Recipients Clinical research trials and Steroid Withdrawal in Pediatric Kidney Transplant Recipients health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Steroid Withdrawal in Pediatric Kidney Transplant Recipients. Steroid Withdrawal in Pediatric Kidney Transplant Recipients Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Steroid Withdrawal in Pediatric Kidney Transplant Recipients clinical trial. Human subjects often get the best healthcare available for their Steroid Withdrawal in Pediatric Kidney Transplant Recipients condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Steroid Withdrawal in Pediatric Kidney Transplant Recipients  Steroid Withdrawal in Pediatric Kidney Transplant Recipients
Steroid Withdrawal in Pediatric Kidney Transplant Recipients
For Condition: End-Stage Renal Disease
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to examine the effects of withdrawing steroids on graft rejection and kidney functions in kidney transplant recipients. Graft survival has improved in recent years in children with kidney transplants. One bad side effect of steroid maintenance therapy has been growth retardation. Doctors believe steroids might be safely withdrawn in patients that are receiving other maintenance therapies. If steroids are removed, children might catch up in their growth and also might have fewer side effects of other kinds. This study measures whether steroid therapy can be withdrawn in a way that does not increase graft rejection.
Details: Children receiving renal transplants face distressing issues in post-transplantation including growth retardation directly attributable to corticosteroids. It is hypothesized that robust immunosuppression with sirolimus and calcineurin inhibitors (cyclosporine or tacrolimus) in conjunction with induction therapy should enable successful steroid withdrawal. A steroid-free environment could lessen side effects by enabling a child to achieve catch up growth, reducing the need for anti-hypertensive therapy, and reducing the risk of cardiovascular disease. This trial tests the objective of providing a steroid-free milieu without incurring the risk of increased incidence of acute rejections. Patients are enrolled prior to kidney transplantation and receive standard evaluations. Patients receive induction therapy with basiliximab preoperatively and on Day 4 after surgery. Immunosuppression therapy begins with sirolimus and either cyclosporine or tacrolimus on Day 1 following surgery, and with corticosteroids the day of surgery. Infection prophylaxis with Bactrim is begun on Day 1 after surgery and center-specific anti-CMV therapy is given for all recipients of a CMV positive kidney. At 6 months post-transplant all patients who have not had an episode of acute rejection undergo a graft biopsy. Patients who are confirmed to be free of subclinical rejection are randomized to either undergo complete steroid withdrawal or continue maintenance on daily steroids. Patients receive either steroids or placebo, while continuing other immunosuppressant medications. Patients are segregated into weight groups for steroid withdrawal that occurs over months 7 to 13. Any acute rejection event during withdrawal is confirmed by biopsy and managed with methylprednisolone treatment. Patients are followed for 3 years for analysis of growth rate, blood pressure, lipid profile and renal function as measured by serum creatinine and calculated creatinine clearances. Post-transplant clinic visits are weekly for the first 2 months, every 2 weeks until 13 months, weekly during Month 13, every 2 weeks through Month 18, and monthly until the study ends. Patients who exhibit evidence of acute or subclinical rejection do not continue the steroid withdrawal trial and care is managed by their center.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: /20 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are 0 to 20 years old. - Are receiving the first living- (from a relative or unrelated donor) or cadaver-donor transplant. - Are willing to practice an acceptable method of birth control during the study, if women able to have children. Exclusion Criteria Patients will not be eligible for this study if they: - Have received multiple organs. - Have received 2 or more transplants. - Have an active infection (including tuberculosis), or cancer. - Have used an experimental agent within 4 weeks of transplantation.
Total Enrollment: 600
Location and Contact Information:
Mara Bauman *Recruiting*
Rockville, Maryland, 20850
United States
Recruiting
Additional Information:
Study ID Numbers: DAIT SW01; SW01
Study Start Date: January 2001
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023244
Other End-Stage Renal Disease Studies:
1. An Evaluation of IV Gamma Globulin As a Method to Improve Kidney Transplant Survival in Patients with End-Stage Renal Disease Who are Highly Sensitized to Transplant Antigens
2. Prevention of Kidney Transplant Rejection
3. Kidney Transplants in People with HIV Infection
4. Steroid Withdrawal in Pediatric Kidney Transplant Recipients
5. Pediatric Kidney Transplant without Calcineurin Inhibitors
Related Studies:
Other End-Stage Renal Disease Clinical Trials
Other Maryland Clinical Trials
Other Rockville Clinical Trials
Steroid Withdrawal in Pediatric Kidney Transplant Recipients
|
|
|
|
|
|
|
|
