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Renal Transplant clinical trials

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NCT ID: NCT00239005 Completed - Renal Transplant Clinical Trials

Enteric-Coated Mycophenolate Sodium on Quality of Life in Patients With Gastrointestinal Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation

Start date: September 2005
Phase: Phase 4
Study type: Interventional

This open, multi-center randomized controlled study is designed to investigate the quality of life in patients with mycophenolate mofetil (MMF)-induced gastrointestinal (GI) adverse events after converting to enteric-coated mycophenolate sodium (EC-MPS).

NCT ID: NCT00212979 Completed - Renal Transplant Clinical Trials

Measuring Kidney Function in Kidney Transplantation

Start date: April 2004
Phase: N/A
Study type: Observational

Kidney transplantation is the preferred treatment for permanent kidney failure. Following transplantation, the kidney function must be followed closely to detect problems so that investigations and appropriate treatment can be started early. Currently, function is monitored with the use of serum creatinine. In clinical trials involving kidney transplant recipients, markers of kidney function, such as serum creatinine, are increasingly being used as outcomes to evaluate new treatments. However, serum creatinine is not very accurate or sensitive at detecting change in kidney transplant function. Newer methods of evaluating kidney function, such as the Modification of Diet in Renal Disease (MDRD) equation and cystatin C, are known to be accurate markers of function in patients with non-transplant kidney disease. This study will compare the MDRD estimate and cystatin C estimate of kidney function with an accepted method (radioisotope clearance study) of measuring true kidney function in 250 renal transplant patients. Each patient will have 2 measurements made at least 3 months apart to determine the accuracy and responsiveness to change over time for the MDRD equation and cystatin C. If the results demonstrate that these new methods are accurate then clinical care and research studies involving transplant patients will be greatly enhanced. Patients and physicians would have a simple test that could detect problems earlier and more precisely monitor response to treatment leading to improved outcomes for renal transplant recipients.

NCT ID: NCT00149929 Completed - Renal Transplant Clinical Trials

Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301

Start date: December 1999
Phase: Phase 3
Study type: Interventional

Aim of study is to collect long term safety and tolerability data on enteric-coated mycophenolate sodium with regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of study CERL080A301 study, patients who previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert from MMF to enteric-coated mycophenolate sodium.

NCT ID: NCT00149916 Completed - Renal Transplant Clinical Trials

Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A0107

Start date: April 2000
Phase: Phase 3
Study type: Interventional

Aim of study is to provide safety and tolerability data on enteric-coated mycophenolate sodium in regard to adverse events, serious adverse events and patient and graft survival. After successful completion of the study CERL080A0107 study, patients could continue to receive enteric-coated mycophenolate sodium.

NCT ID: NCT00149903 Completed - Renal Transplant Clinical Trials

Study of Enteric-coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant Patients

Start date: January 2005
Phase: Phase 3
Study type: Interventional

Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant patients.

NCT ID: NCT00149864 Completed - Renal Transplant Clinical Trials

Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A302

Start date: February 2000
Phase: Phase 3
Study type: Interventional

Aim of study is to collect long term safety data on enteric-coated mycophenolate sodium 720 mg bid in combination with cyclosporine with/without steroids in regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of the study CERL080A302, patients who previously were receiving enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert MMF to enteric-coated mycophenolate sodium.

NCT ID: NCT00141037 Completed - Clinical trials for Kidney Transplantation

Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation

Start date: March 2004
Phase: Phase 1/Phase 2
Study type: Interventional

Over the last 40 years, corticosteroids (steroids) have been an important part of drug regimens used to prevent organ rejection and to maintain the immune health of individuals who have received organ transplants. Unfortunately, the negative physical effects of steroids can be severe, especially in children. The purpose of this study is to determine the safety and effectiveness of a steroid-free treatment regimen for children and adolescents who have received kidney (renal) transplants.