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Renal Transplant clinical trials

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NCT ID: NCT00555373 Completed - Renal Transplant Clinical Trials

Pediatric Kidney Transplant Study of Sirolimus, Mycophenolate Mofetil, and Corticosteroids vs Calcineurin Inhibitor Based Immunosuppression

CNI-W
Start date: November 2007
Phase: N/A
Study type: Interventional

Damage and scarring of a transplanted kidney has become the most common cause of loss of the transplanted kidney. This kidney damage is a complex process caused by many factors including injury during obtaining and transplanting the kidney, injury from the immune system, injury from infections, and injury from drugs used to stop rejection. This injury leads to scars that decrease the kidney's ability to function properly, and over time the kidney is lost. Prograf® (tacrolimus) has been one of the main drugs used to prevent rejection. However, when used over time it has been shown to cause chronic damage and scarring in the transplanted kidney. The purpose of this experimental study is to determine whether children can safely be withdrawn from Prograf® after transplantation and changed to Rapamycin® (sirolimus). Recent research studies in adult transplantation have demonstrated that with the use of Rapamycin® (sirolimus), it is possible to discontinue the use of Prograf (tacrolimus) with no increase in rejection, with decreased scarring in the kidney, and with improvements in kidney function and survival of the kidney. A total of 50 children will enroll in this study at university centers around the country. This study will last about 3 years.

NCT ID: NCT00547040 Completed - Atherosclerosis Clinical Trials

Arterial Stiffness and Calcifications in Incident Renal Transplant Recipients

ASCIT
Start date: October 2006
Phase:
Study type: Observational

The purpose of this study is to determine the: - Natural history of calcification posttransplantation - Natural history of BMC following renal transplantation - Reverse correlation between calcification score and aortic calcifications following renal transplantation - Correlation of IMT, BMC, PWV and biochemical variables - Correlation of IMT, BMC, PWV, biochemical variables and outcome - Predictors of CV disease after transplantation - Predictors of IMT progression, BMC loss and PWV progression after renal transplantation

NCT ID: NCT00529269 Completed - Renal Transplant Clinical Trials

Measurement of Patient Reported Outcomes in Korean Renal Transplant Patients With and Without Gastrointestinal (GI) Symptoms

Start date: December 2006
Phase: Phase 4
Study type: Interventional

This study will evaluate the impact that GI complaints have on patient-reported outcomes and to determine if there is improvement in patient-reported outcomes when converted from mycophenolate mofetil (MMF) to Enteric-coated mycophenolate sodium (EC-MPS)

NCT ID: NCT00478608 Completed - Renal Transplant Clinical Trials

Study Evaluating Rapamune® Maintenance Regimen

Start date: March 2007
Phase: Phase 3
Study type: Interventional

Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients. Secondary : 1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients. 2. To evaluate graft function, patient survival and graft survival at 6 and 12 months after transplantation, and to investigate the incidence of biopsy-confirmed acute rejection episode at 12 months after transplantation.

NCT ID: NCT00402168 Completed - Renal Transplant Clinical Trials

A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids

Start date: January 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn if conversion to belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied

NCT ID: NCT00365846 Completed - Renal Transplant Clinical Trials

"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation"

Start date: August 2000
Phase: Phase 2
Study type: Interventional

The purpose of the study is to see if campath-1H can be used in first time renal transplant subjects to prevent rejection and reduce the overall amount of anti-rejection medications that patients take on a daily basis.

NCT ID: NCT00352547 Completed - Renal Transplant Clinical Trials

Influence of Genes on Sirolimus Metabolism in Patients With Kidney Transplantation

Start date: May 21, 2004
Phase: N/A
Study type: Observational

This study will evaluate the effects of certain genes (MDR-1, CYP3A4, and CYP3A5) on metabolism of the drug sirolimus, an immune-suppressing drug given to transplant recipients to prevent organ rejection. Individual differences in metabolism and excretion of sirolimus affect the patient's response to treatment. Patients who have undergone kidney transplantation at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Transplant Branch and have received sirolimus treatment will be enrolled in this study. DNA (genetic material) will be extracted from blood samples collected from transplant recipients to determine their MDR-1, CYP3A4, and CYP3A5 genotypes. Patient demographic information and data on sirolimus metabolism and excretion will be collected from the medical information system, NIDDK transplant database, and the patients' medical records. The data will be compared among patients with different genotypes (genetic constitution of an individual) and haplotypes (set of genes that code for different proteins but are inherited as a unit) to determine the effect of these gene variations on sirolimus metabolism. Information from this study may be applied to developing better dosing strategies, and thus, treatment outcomes for transplant patients receiving sirolimus.

NCT ID: NCT00352092 Completed - Renal Transplant Clinical Trials

Pilot Study for HLA Identical Living Donor Renal Transplant Recipients

Start date: June 2002
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of a steroid-free and calcineurin-inhibitor free treatment regimen for patients who are receiving a kidney transplant from a living donor that is HLA-identical (has a similar immune system).

NCT ID: NCT00332410 Completed - Renal Transplant Clinical Trials

Intravenous Voriconazole in Patients With Renal Compromise

Start date: May 2006
Phase:
Study type: Observational

The purpose of this study is to determine whether patients with compromised renal function (CrCl < 50mL/min) receiving intravenous voriconazole experienced any adverse effects related to serum chemistries or other imaging studies of the kidney due to the potential accumulation of the vehicle cyclodextran.

NCT ID: NCT00270153 Completed - Renal Transplant Clinical Trials

The Use of ACE Inhibitors in the Early Renal Post-transplant Period

Start date: September 2004
Phase: Phase 1
Study type: Interventional

Chronic allograft nephropathy (CAN) is the leading cause of longterm renal transplant loss. Angiotensin-II may play a role in the development and progression of CAN. Angiotensin converting enzyme inhibitors (ACEI) comprise a drug class that inhibit the effects of angiotensin-II. However these drugs have been reported to cause elevated potassium and creatinine levels in some renal transplant patients. Yet, there are now several retrospective reports of long term benefits of improved renal function and graft survival in renal transplant recipients. There have been no reports of prospective randomized controlled trials of ACEI in renal transplant patients in the early post transplant period. The purpose of the present study is to assess the safety of enalapril, a drug in the ACEI class, when started 1-3 month post transplant. This is a double-blinded, randomized control trial of enalapril vs. placebo in new renal transplant patients with serum creatinine values no higher than 2.5mg/dl and normal serum potassium levels. The study drug will be administered for 6 months. Patients will be monitored in the renal transplant clinic every 1-4 weeks according to routine protocol. Clinical end-points will be occurence of potassium >5.9mEQ/L or sustained increase in serum creatinine >30% from baseline.