Advertisement

Topics

CNI-free "Bottom"-up Immunosuppression in Patients Undergoing Liver Transplantation With MELD-scores>25 and/or an eGFR (Abbreviated MDRD-Formula) ≤50 mL/Min

2014-08-27 03:17:37 | BioPortfolio

Summary

The primary objective of the trial is to evaluate efficacy and safety of delayed introduction (up to 30 days post-transplantation in patients without signs of acute rejection that had received an aIL-2 induction and MMF) of either cyclosporine or everolimus versus a 5-day delay of cyclosporine in combination with MMF.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Renal Impairment

Intervention

delayed, low-dose CNI, BU-CNI, BU-Everolimus

Location

Regensburg University Hospital
Regensburg
Bavaria
Germany
93053

Status

Not yet recruiting

Source

University of Regensburg

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:37-0400

Clinical Trials [2163 Associated Clinical Trials listed on BioPortfolio]

Extension Study to CRAD001A1202

Until 24 months after renal transplantation, this study is designed to evaluate the long-term safety and efficacy comparing concentration-controlled everolimus with reduced dose Neoral® a...

ASCERTAIN: Assessment of Everolimus in Addition to Calcineurin Inhibitor Reduction in the Maintenance of Renal Transplant Recipients

The study is designed to evaluate whether the initiation of everolimus together with the reduction or discontinuation of calcineurin inhibitors (CNIs) will improve graft function in the ma...

Everolimus in de Novo Heart Transplant Recipients

The purpose of this study, in de novo heart transplant patients, is to evaluate whether delayed introduction of everolimus reduces the occurrence of wound healing problems, pericardial and...

Pharmacokinetics of Everolimus and Enteric-Coated Mycophenolatesodium Before and After Withdrawal of Cyclosporine in Renal Transplant Patients

Cyclosporine (CNI), a potent immunosuppressive drug used in transplant recipients to prevent graft rejection, can cause renal impairment in some patients. The aims of this study are - ...

Everolimus and Low Dose CNI Compared With MMF and Full CNI Dose in Heart Transplanted Patients: One Year Follow up

The different mechanisms of action of Everolimus and cyclosporine suppress immune function in synergistic manner. Thus it is postulated that the use of Everolimus in combination with cyclo...

PubMed Articles [10174 Associated PubMed Articles listed on BioPortfolio]

Prediction of Tacrolimus Exposure by CYP3A5 Genotype and Exposure of Co-Administered Everolimus in Japanese Renal Transplant Recipients.

While tacrolimus and everolimus have common metabolic pathways through CYP3A4/5, tacrolimus is metabolized solely by CYP3A4 in recipients with the/. The purpose of this study was to evaluate how the a...

Pharmacokinetics and Safety of Momelotinib in Subjects With Hepatic or Renal Impairment.

Momelotinib is a Janus kinase 1/2 inhibitor in clinical development for the treatment of myelofibrosis. Two phase 1 open-label, parallel-group, adaptive studies were conducted to evaluate the pharmaco...

Clinical validation study of dried blood spot for determining everolimus concentration in patients with cancer.

Everolimus treatment is seriously hampered by its toxicity profile. As a relationship between everolimus exposure and effectiveness and toxicity has been established, early and ongoing concentration m...

Effect of Renal Impairment on the Pharmacokinetics and Pharmacodynamics of Verinurad, a Selective Uric Acid Reabsorption Inhibitor.

BACKGROUND AND OBJECTIVE: Verinurad (RDEA3170) is a high-affinity, selective URAT1 transporter inhibitor in development for treating gout and asymptomatic hyperuricemia. This Phase I, single-dose stu...

Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation.

Everolimus permits reduced calcineurin inhibitor (CNI) exposure, but the efficacy and safety outcomes of this treatment after kidney transplant require confirmation. In a multicenter noninferiority tr...

Medical and Biotech [MESH] Definitions

The prototypical uricosuric agent. It inhibits the renal excretion of organic anions and reduces tubular reabsorption of urate. Probenecid has also been used to treat patients with renal impairment, and, because it reduces the renal tubular excretion of other drugs, has been used as an adjunct to antibacterial therapy.

The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.

A treatment schedule in which the total dose of radiation is divided into large doses.

A genus of mushrooms in the family Cortinariaceae. When ingested, species of Cortinarius cause delayed acute RENAL FAILURE.

Two closely related polypeptides (molecular weight 7,000) isolated from the thymus gland. These hormones induce the differentiation of prothymocytes to thymocytes within the thymus. They also cause a delayed impairment of neuromuscular transmission in vivo and are therefore believed to be the agent responsible for myasthenia gravis.

More From BioPortfolio on "CNI-free "Bottom"-up Immunosuppression in Patients Undergoing Liver Transplantation With MELD-scores>25 and/or an eGFR (Abbreviated MDRD-Formula) ≤50 mL/Min"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Transplantation
Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...

Nephrology - kidney function
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...


Searches Linking to this Trial