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Renal Transplant clinical trials

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NCT ID: NCT01334333 Completed - Renal Disease Clinical Trials

Comparison of Medication Adherence Between Once and Twice Daily Tacrolimus in Stable Renal Transplant Recipients

Start date: November 11, 2011
Phase: Phase 4
Study type: Interventional

A critical aspect of real-world functioning following kidney transplantation involves how adherent individuals are to their medication regimens. Regardless of the possible dangers of failing to adhere to anti-rejection medications, such as increased graft rejection, studies have reported rates of non-adherence at almost 50% following renal transplant. The Cognitive Aging Laboratory under the direction of Dr. Wendy Thornton, at Simon Fraser University, has previously identified relationships between several potentially important cognitive and psychosocial variables, and self-reported medication adherence in renal transplant recipients, including depressive symptoms, as well as everyday and traditional cognitive functioning [4]. The possibility that changes in dosing regimens for a given medication may have an additional impact on medication adherence presents an important issue worth further exploration. The current study will allow for more thorough delineation of the roles of psychosocial and cognitive predictors of adherence with state-of-the-art monitoring techniques. In addition, the investigators will assess whether different dosing formulations of tacrolimus impact adherence behaviors in renal transplant recipients. The proposed research has two primary aims to examine: 1. To examine the role of cognitive and psychosocial variables in predicting medication adherence in renal transplant recipients. 2. To examine whether different formulations of tacrolimus (once per day dosing versus twice per day dosing) will impact medication adherence in renal transplant recipients.

NCT ID: NCT01256294 Completed - Renal Transplant Clinical Trials

Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients

Start date: October 2010
Phase: Phase 4
Study type: Interventional

The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to branded tacrolimus (Prograf) in stable renal transplant patients.

NCT ID: NCT01224860 Completed - Renal Transplant Clinical Trials

Telmisartan Versus Losartan in Kidney Transplantation

COSTANT
Start date: January 2009
Phase: Phase 2
Study type: Interventional

In renal transplant recipients, residual renal insufficiency combined to the effects of immunosuppressive therapy with steroids or calcineurin inhibitors may reduce insulin activity and may contribute to several of the abnormalities associated with the metabolic syndrome, such as hypertension, glucose intolerance and hyperlipidemia. In turn, insulin resistance, hypertension, hyperglycemia and dyslipidemia may importantly contribute to the excess cardiovascular risk of renal transplant patients (an excess comparable to that of diabetes subjects with over diabetic nephropathy)and may also accelerate progressive renal function deterioration and promote graft loss. Thus, amelioration of the insulin activity and of the related metabolic syndrome is a key component of treatments aimed to improve patient and graft survival in renal transplant recipients. Recently, drugs such as peroxisome proliferators-activated receptor-gamma activators, that ameliorate insulin sensitivity and metabolic syndrome, have become available.These agents, however, can provoke fluid retention, weight gain, edema and, in some cases, heart failure. Recent studies showed that telmisartan, an angiotensin II type 1 receptor antagonist, in addition to block the angiotensin II type 1 - a key surface receptor involved in the regulation of blood pressure - may also activate peroxisome proliferators-activated receptor-gamma activators, thus improving some of the features of the metabolic syndrome. Thus telmisartan may substantially reduce the overall cardiovascular and renal risk of renal transplant recipients by ameliorating some of the modifiable components of the metabolic syndrome. On the other hand, telmisartan is devoid of the adverse effects of peroxisome proliferators-activated receptor-gamma activators such as fluid retention, and has therefore a remarkably better risk/benefit profile. Thus, whether telmisartan in addition to the beneficial effects of a reference angiotensin II type 1 receptor antagonist (such as losartan) may offer adjunctive advantages related to improved insulin sensitivity in renal transplant patients on chronic therapy with steroids and/or calcineurin inhibitors, is worth investigating.

NCT ID: NCT01220050 Completed - Clinical trials for Secondary Hyperparathyroidism

Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism

APPLE
Start date: September 2009
Phase: Phase 2
Study type: Interventional

The risk of fracture for kidney transplant recipients is 4 times higher that of the general population. The hyperparathyroidism plays a key role in the maintenance or development of post-transplant alterations of bone remodelling. Renal transplant patients are at high risk of hyperparathyroidism, largely because of long-lasting renal insufficiency before transplant, and of progressive deterioration of kidney function because of chronic allograft nephropathy (a disease of proteinuria and progressive decline of the glomerular filtration rate).In hemodialysis patients, intravenous paricalcitol (19-nor-1,25-dihydroxyvitamin D2), a new vitamin D analogue, achieves a faster and more effective normalization of parathyroid hormone (PTH) levels than calcitriol (1,25-dihydroxyvitamin D3), an effect that is associated with smaller changes in serum calcium and phosphorus levels. Whether oral paricalcitol may help achieving a prompt reduction in serum PTH levels and, secondarily, in urinary protein excretion in renal transplant recipients with secondary hyperparathyroidism is worth investigating.

NCT ID: NCT01169701 Completed - Renal Transplant Clinical Trials

24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients

EVITA
Start date: August 2010
Phase: Phase 4
Study type: Interventional

The objective of the study is to compare the cardiovascular profile of an everolimus and mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic acid regimen in maintenance renal transplant patients

NCT ID: NCT01028092 Completed - Renal Transplant Clinical Trials

mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation

EVEROLD
Start date: March 2009
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate efficacity and safety of everolimus or (cyclosporine then everolimus) vs. cyclosporine as immunosuppressive treatment in renal transplantation for elderly (>60 years old) recipients receiving graft from elderly donor(>60 years old).

NCT ID: NCT00895583 Completed - Kidney Transplant Clinical Trials

Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients

Start date: June 2009
Phase: Phase 4
Study type: Interventional

This study will look at the effect on long-term kidney function using tacrolimus right after a transplant and then switching to sirolimus at 3 to 5 months after the transplant.

NCT ID: NCT00881582 Completed - Chronic Hepatitis C Clinical Trials

Peginterferon Alfa-2a Plus Ribavirin Combination Treatment in Chronic Hepatitis C Post-Renal Transplant Patients

Start date: January 2009
Phase: Phase 4
Study type: Interventional

There is a distinct lack of published literature on the effect of combination treatment of PEG-interferon and ribavirin on post-renal transplantation hepatitis C virus (HCV) patients. Small case series have been published utilizing conventional interferon and/or ribavirin and the available data is extremely preliminary in nature. A small retrospective series of patients treated with Pegylated interferon and ribavirin published recently suggests that the treatment may be safe and efficacious. Unpublished reports from a few centers within Saudi Arabia also suggest a good safety profile and reasonable efficacy from this form of combination treatment. The investigators aim to prospectively study the safety and efficacy of PEG-interferon and ribavirin combination therapy in post-renal transplant HCV-infected patients. Towards this 40 patients with histological evidence of liver disease will be recruited and the efficacy of the above medications studied. The proposed study aims to evaluate the efficacy and safety of PEG-interferon and ribavirin combination therapy in the treatment of chronic HCV in renal transplant patients in a way that will allow management of such patients in an optimized manner.

NCT ID: NCT00820469 Completed - Autoimmune Diseases Clinical Trials

Study of the Influence of Plasma Exchange on the Pharmacokinetics of Rituximab

PK-rituximab
Start date: September 2008
Phase: Phase 4
Study type: Interventional

Rituximab (a monoclonal antibody raised against CD20) is used to treat various immune disorders. In some cases such as treatment of humoral acute rejection of renal transplant, thrombotic thrombocytopenic purpura, vasculitis or cryoglobulinemia, rituximab is often associated with plasma exchange. The pharmacokinetic of the rituximab can be affected by plasma exchange but the knowledge is poor in this matter. The aim of the study is to explore the influence of plasma exchange on the pharmacokinetic of rituximab. The results of this study should conclude if plasma exchange leads to a significant decrease of plasma concentration of rituximab or not, and if the decreased of the concentration is associated with a decrease in efficacy.

NCT ID: NCT00682045 Completed - Renal Transplant Clinical Trials

Latent Tuberculosis Infection in Renal Transplant Recipients

Start date: June 2008
Phase: N/A
Study type: Observational

The aim of this study is to estimate the usefulness of a T cell-based assay (i.e. T-SPOT.TB assay) for diagnosis of latent tuberculosis infection (LTBI) in renal transplant recipients. For this purpose, the investigators enrolled renal transplant recipients and observed the developement of tuberculosis within 1 to 2 years after the transplantation.