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A Study to Compare Treatment with Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on A Study to Compare Treatment with Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Study to Compare Treatment with Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant Clinical research trials and A Study to Compare Treatment with Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including A Study to Compare Treatment with Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant. A Study to Compare Treatment with Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a A Study to Compare Treatment with Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant clinical trial. Participants typically obtain the most effective healthcare available for their A Study to Compare Treatment with Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study to Compare Treatment with Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant  A Study to Compare Treatment with Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant
A Study to Compare Treatment with Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant
For Condition: Kidney Transplantation,End-Stage Renal Disease
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to compare treatment with the new drug sirolimus (SRL) versus the standard treatment with cyclosporine (CsA) or tacrolimus in children who have received kidney transplants. SRL is a new medication that may prevent the body's immune system from rejecting organ transplants. After receiving a kidney transplant, the body recognizes the donated kidney as a foreign invader and triggers the immune system to attack the kidney. This can lead to rejection of the new kidney and a failed transplant. To help reduce the risk of kidney rejection, transplant patients are given immunosuppressant drugs, which reduce the body's normal immune response and allow the transplanted organ to function. CsA or tacrolimus are two drugs that are often given to transplant patients. However, these are powerful drugs, and it can cause serious side effects and put a patient at increased risk for infections. SRL is a new drug that has been shown to reduce a transplant patient's chance of rejecting a new kidney, without serious side effects. This study is necessary to test the safety and effectiveness of SRL in children.
Details: Successful kidney transplantation has gradually improved over the years; much of the improvement has resulted from the use of CsA. However, adequate and tolerable immunosuppression is difficult to achieve with CsA, and rejection episodes are still frequent. CsA is nephrotoxic, with drug toxicity often masking rejection episodes. Other immunosuppressant therapies can result in a range of complications, including metabolic disturbances, adrenocortical insufficiency, and increased risk for infections. Therefore, more effective drugs with less toxicity are needed to prevent acute rejection, especially in the pediatric population where the overall graft survival rate remains significantly lower when compared with that of adult transplant recipients. SRL is an immunosuppressive agent being developed for the prophylaxis of acute renal allograft rejection. SRL has a unique mechanism of action. It inhibits T and B cell activity. In Phase I and II trials in adults, SRL was generally well tolerated and exhibited no apparent nephrotoxic properties, and significantly lower rates of rejection were seen with SRL when compared to placebo. Patients receive extensive prestudy screening, which includes a renal core biopsy, chest x-ray, bone density study, blood tests, and glomerular filtration rate (GFR). Patients are then randomly assigned to 1 of 2 study treatment groups in a 2:1 ratio (142 patients receive SRL, CsA/tacrolimus, and corticosteroids and 71 patients receive standard CsA or tacrolimus-based double or triple drug therapy). SRL is administered as an oral dose of 3 mg/m2/day. Patients are followed for 3 years on therapy, and then for 1 month of follow-up. A renal core biopsy is performed at the time of study entry and at Months 6, 18, and at early termination of patient in study. Patients undergo physical examinations and various blood tests at specified time intervals during the 37-month study period. Efficacy is assessed by comparing the composite endpoint of biopsy-proven acute rejection, graft loss, or death after 36 months of treatment. Safety is assessed by comparing the composite endpoint of graft loss or death after 36 months of treatment.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: /20 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Your child may be eligible for this study if he/she: - Has received a kidney transplant. - Has experienced 1 or more episodes of acute rejection or chronic rejection; a rejection episode must have responded to treatment and have occurred at least 30 days before study enrollment. - Has stable kidney function at the time of study enrollment. - Is 20 years of age or younger. - Has written informed consent of parent or guardian if under the age of 18. - Agrees to use birth control during the study and for 3 months following treatment. Exclusion Criteria Your child will not be eligible for this study if he/she: - Has a history of cancer. - Has received a multi-organ transplant (more than a kidney). - Has an active infection. - Has an abnormal chest X-ray. - Cannot provide a kidney biopsy at time of study entry. - Is allergic to sirolimus. - Has received experimental drugs within 4 weeks of study entry. - Is pregnant.
Total Enrollment: 213
Location and Contact Information:
Ilene Blechman-Krom
Rockville, Maryland, 20850
United States
Additional Information:
Study ID Numbers: DAIT 0468E1-217-US; SRL1
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005113
Other End-Stage Renal Disease Studies:
1. End- Stage Renal Disease – High Risk Transplant Recipients
2. 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
3. Steroid Withdrawal in Pediatric Kidney Transplant Recipients
4. A Study to Compare Treatment with Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant
5. Pediatric Kidney Transplant without Calcineurin Inhibitors
Related Studies:
Other End-Stage Renal Disease Clinical Trials
Other Maryland Clinical Trials
Other Rockville Clinical Trials
A Study to Compare Treatment with Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant
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