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Kidney Transplantation clinical trials

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NCT ID: NCT00885820 Completed - Clinical trials for Kidney Transplantation

Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

Start date: September 2001
Phase: Phase 4
Study type: Interventional

This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection versus a non-protocol biopsy control group.

NCT ID: NCT00865137 Completed - Clinical trials for Kidney Transplantation

An Open Study Assessing Bioavailability of a Modified Formulation of Tacrolimus in Kidney Transplant Recipients

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

The purpose of this study is to evaluate the effect of food on the oral bioavailability of tacrolimus modified release (MR4) capsules together with a standard continental breakfast. The objective is to assess the pharmacokinetics and relative bioavailability with and without food.

NCT ID: NCT00842322 Completed - Clinical trials for Kidney Transplantation

Fluid Intake in Kidney Failure

Start date: n/a
Phase: N/A
Study type: Interventional

Patients with renal impairment are usually advised to increase their fluid intake. There is currently, however, no evidence supporting this recommendation. In contrast,high fluid intake could be dangerous if urine excretion is reduced. In this study the researchers investigate whether increasing fluid intake from 2 to 4 litres per day has any influence on long-term renal outcome.

NCT ID: NCT00833651 Completed - Immunosuppression Clinical Trials

Protective Immunity Project 02

PIP-02
Start date: November 2006
Phase: N/A
Study type: Observational

Influenza (Flu) vaccine is recommended for kidney transplant patients who are at least 6 months post-transplant. The influenza vaccine stimulates the immune system to builds protective antibodies against the flu virus. Previous research has shown that adult kidney transplant patients are not able to form as much of these protective antibodies as compared to healthy volunteers. Research has also suggested that different immunosuppressive medicines may have different effects on antibody formation. In this study, we hope to evaluate these differences in more detail. In recent years, increasingly effective, but also increasingly complex, immunosuppressive regimens have been developed, however, there has been little detailed systematic study of the immune changes that occur in response to vaccination with these newer immunosuppressive regimens.Current policies on vaccination of transplant recipients are generic and continue to be based on old concepts rather than on any new understanding of the effects of these newer therapies on the immune system. We hope to improve our understanding of the effects of the immunosuppressive regimens in use today (calcineurin-inhibitor, or CNI, and sirolimus-based regimens) on immune response to flu vaccine. Such knowledge will be critical to helping clinicians develop strategies for getting desirable immune responses while not causing rejection.

NCT ID: NCT00820911 Completed - Clinical trials for Kidney Transplantation

Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients

Start date: September 2008
Phase: Phase 2
Study type: Interventional

This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.

NCT ID: NCT00817687 Completed - Clinical trials for Kidney Transplantation

A Study of the Impact of an Early Biopsy in Patients Treated With CellCept (Mycophenolate Mofetil) After Kidney Transplantation

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

This 2 arm study will evaluate the impact on fibrosis at week 52 of an early biopsy, in patients who have received a kidney transplant from an expanded criteria donor. Patients will be randomized to one of two groups; the first group will have a biopsy at day 10, and the second group will receive standard management. All patients will be given CellCept as standard of care. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

NCT ID: NCT00812123 Completed - Clinical trials for Chronic Kidney Disease

Calcineurin Free Immunosuppression in Renal Transplant Recipients

Start date: January 2001
Phase: Phase 4
Study type: Interventional

The main purpose of this study is to obtain preliminary information on the efficacy, safety and cost of two regimens, Rapamycin / MMF / steroid therapy and Cyclosporine A Neoral / MMF / steroid therapy, used in the prevention of acute rejection following renal transplantation.

NCT ID: NCT00811915 Completed - Clinical trials for Kidney Transplantation

Study to Compare the Safety and Efficacy of Sirolimus (Rapamune) to Tacrolimus (Advagraf) Associated to Mycophenolate Mofetil (CellCept) Between 12 and 36 Months After Kidney Transplantation

EPARGNE
Start date: January 2009
Phase: Phase 3
Study type: Interventional

The use of tacrolimus in the long term as part of the immunosuppressive regimen after transplantation is associated to complications such as chronic nephrotoxicity, impaired glucose metabolism (diabetes mellitus) and an increase of the incidence of neoplasia. The conversion from a tacrolimus based therapy to a sirolimus based therapy associated with mycophenolate mofetil could improve the incidence of such complications. The aim of this study is to assess the risk/benefit ratio of this switch performed in stable renal transplant recipient between 12 months and 36 months after transplantation. The incidence of a composite endpoint (worsening of GFR evaluated by MDRD formula, incidence of cancer and diabetes) will be assessed 24 months after conversion.

NCT ID: NCT00805571 Completed - Clinical trials for Kidney Transplant Dysfunction

Urinary Kidney Injury Molecule-1 (KIM-1) Excretion As Biomarker for Injury in Kidney Transplant Recipients

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

The purpose of this study is to determine if measuring the level of a protein called Kidney Injury Molecule-1 (KIM-1) in the urine will help healthcare providers detect any problems with the transplanted kidney before the laboratory investigations that are used on a routine basis do. This approach may allow the doctor to intervene at an earlier point of a rejection episode and may thereby prolong survival of the transplant kidney.

NCT ID: NCT00801632 Completed - Clinical trials for Kidney Transplantation

Combined Kidney and Bone Marrow Transplantation to Prevent Kidney Transplant Rejection

Start date: December 2008
Phase: Phase 2
Study type: Interventional

In small initial studies, combined kidney and bone marrow transplants from the same donor have permitted some individuals to stop taking anti-rejection medicines without rejecting their transplant. This clinical trial will study this method in a greater number of people to determine if it is indeed effective and safe.