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Kidney Transplantation clinical trials

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NCT ID: NCT01710033 Completed - Kidney Transplant Clinical Trials

A Study Of CP-690,550 In Stable Kidney Transplant Patients

Start date: September 2003
Phase: Phase 1
Study type: Interventional

This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort in Stage 2.

NCT ID: NCT01707550 Completed - Clinical trials for Kidney Transplantation

An Observational Study of CellCept (Mycophenolate Mofetil) in Renal Allograft Recipients

Start date: December 2009
Phase: N/A
Study type: Observational

This observational survey study will capture all renal transplant patients in Serbia who are currently receiving CellCept (mycophenolate mofetil) as part of their immunosuppressive protocol.

NCT ID: NCT01702207 Completed - Clinical trials for Cardiovascular Diseases

Evaluation Of Switching From Twice Daily Tacrolimus To Once Daily Formulation On Cardiovascular Risk

ESTTEROD
Start date: October 2012
Phase: Phase 4
Study type: Interventional

Current standard prophylactic immunosuppression in renal transplantation includes tacrolimus, a calcineurin inhibitor, dosed twice daily. In Canada, oral tacrolimus has been available as a twice daily formulation marketed as Prograf® since 1997. It has recently become available in an extended release formulation called Advagraf®, which is dosed once daily. Advagraf® has been demonstrated to be therapeutically equivalent to Prograf® in the renal transplant maintenance population, and as a result it has been is approved as an alternative to the twice daily formulation in these patients. There is an evolving and expanding positive clinical experience with Advagraf® in kidney transplantation and it has shown to be preferred by many patients, due to the diminished dosing frequency. In clinical trials, Advagraf® has been shown to have other potential benefits over Prograf® such as less inter and intra-patient variability, improved cardiovascular profiles, and improved kidney function. Compared to Prograf®, Advagraf® also has a lower Cmin or 'trough' concentration as well as a lower Cmax or 'peak' concentration. The purpose of this study is to convert stabilized renal transplant patients currently receiving Prograf® to Advagraf®, to investigate these potential therapeutic benefits. The Framingham Risk Score and the Reynold's Risk Score are currently recommended by the Canadian Cardiovascular Society (CCS) to predict 10-year cardiovascular risk in the general population. Surrogate markers are widely used in clinical trials to shorten follow-up durations. In this study, the investigators will use the Framingham Risk Score and Reynold's Risk Score to quantify changes in estimated cardiovascular risk. The investigators also intend to examine novel inflammatory markers to investigate cardiovascular risk. The investigators hypothesize that the more consistent drug exposure and lower Cmax noted with Advagraf® will decrease Framingham Risk Score, Reynolds Risk score as well as markers of inflammation in kidney transplant recipients.

NCT ID: NCT01680952 Completed - Clinical trials for Kidney Transplant Patients

Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients

Start date: September 2012
Phase: Phase 4
Study type: Interventional

This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil in Kidney Transplant Patients.

NCT ID: NCT01672957 Completed - Clinical trials for Kidney Transplantation

ORANGE Study: An Observational Study on Renal Function in Kidney Transplant Patients on Immunosuppressive Therapy Containing CellCept (Mycophenolate Mofetil)

Start date: September 2011
Phase: N/A
Study type: Observational

This observational study will evaluate renal function in patients who underwent renal allograft transplantation and are started on combined immunosuppressive treatment containing CellCept (mycophenolate mofetil). Eligible patients will be followed for 12 months following transplantation.

NCT ID: NCT01656343 Completed - Clinical trials for Kidney Transplantation

Belatacept and Risk of Post-transplant Lymphoproliferative Disorder in US Renal Transplant Recipients

Start date: October 31, 2011
Phase:
Study type: Observational

- To estimate the incidence rates of post-transplant lymphoproliferative disorder (PTLD) in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept at the time of transplantation - To estimate the incidence rates of PTLD in adult, EBV seropositive, kidney alone transplant recipients treated with calcineurin inhibitors (CNI)-based regimens at the time of transplantation - To compare the PTLD incidence rates in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept to the rates in adult, EBV seropositive, kidney alone transplant recipients treated with CNI-based regimens at the time of transplantation

NCT ID: NCT01655563 Completed - Clinical trials for Kidney Transplantation

Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation

Start date: September 2011
Phase: Phase 2
Study type: Interventional

Tacrolimus is a standard and widely used maintenance immunosuppressive agent after solid organ transplantation.The purpose of this trial is to determine if dosing of tacrolimus through genetics will help in early attainment and maintenance of the correct dosage level in the early post-transplant period. This pilot dose-finding trial will help to determine a dosing strategy guided by genotypes and age for solid organ transplant recipients that will be further validated through a multi-centre trial as an immediate next step. The study hypothesizes that dosage levels determined through age and genotype will be attained faster and more accurately than the standard dosing procedures in the 14-days after the transplant. Further, this study hypothesizes that a genotype and age dosing strategy will cause a faster recovery (tested through the kidneys' ability to clear creatine from the blood) and result in lower frequencies of adverse effects and rejection of the transplant.

NCT ID: NCT01653041 Completed - Clinical trials for Kidney Transplantation

Certican (Everolimus) for Recipients of Kidney From HLA-identical Living Donors

Start date: August 2012
Phase: Phase 4
Study type: Interventional

Recipients from living donors kidneys HLA-identical were lower risk for acute rejection, graft loss or death. There is no clear definition of what is ideal immunosuppressive regimen for this population. Everolimus (EVR) was associated with lower incidence of viral infections and also the lowest incidence of neoplasms. Furthermore, immunosuppressive regimens based everolimus allow the reduction or elimination of calcineurin inhibitors reducing cardiovascular risks associated with chronic use of these agents. Moreover, the use of EVR is associated with increased incidence of proteinuria, which associated mechanism has not been fully elucidated. Knowing that proteinuria may be the first indication of recurrence of the underlying renal disease, detailed information about the patient's medical history and histological analysis of the graft may contribute with additional knowledge in this area. The aim of this prospective, open, single arm study that will be performed only in the Hospital do Rim e Hipertensão, is investigating the outcomes of kidney transplantation in recipients of HLA identical living donor, receiving an everolimus-based immunosuppressive regimen. This will include 100 recipients of first or second kidney transplant from a living donor HLA identical to the Kidney and Hypertension Hospital, which will be followed by a period of 12 months.

NCT ID: NCT01640743 Completed - Clinical trials for Kidney Transplantation

Effect of Different Therapeutic Strategies on Regulatory T Cells in Kidney Transplantation

EVERTWIST
Start date: March 2010
Phase: N/A
Study type: Interventional

The objective of the study will be to evaluate the effect of different therapeutic immunosuppressive strategies currently employed in common clinical practice on regulatory T lymphocytes and to verify the hypothesis that the association of thymoglobulins - mTOR inhibitors - small doses of Tacrolimus not only represents a safe anti-rejection therapy but it can also lead to mid-term formation of a high amount of regulatory T cells and, consequently, a high grade of tolerance.

NCT ID: NCT01622881 Completed - Clinical trials for Kidney Transplantation

Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation

Start date: June 2012
Phase: N/A
Study type: Interventional

The investigators examined the efficacy of nefopam in patients undergoing kidney transplantation.