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Immune monitoring to characterize T-cell responses of kidney transplant patients during co-stimulation blockade by belatacept

Here, we postulate that the balance between the effect of belatacept on regulatory T-cell function and the relative insensitivity of memory T-cells for belatacept leads to donor-specific alloreactivity. We plan to study the peripheral CD28-dependent…

A multicentre randomised controlled trial to compare the efficacy of ex-vivo oxygenated hypothermic machine perfusion with non-oxygenated hypothermic machine perfusion of kidneys from donors older than 50 years of age and donated after circulatory death.

To compare the effect of oxygenated versus non-oxygenated hypothermic machine perfusion of grafts of DCD category III (awaiting circulatory death - controlled), kidneys aged 50 years or older on kidney graft function.

Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients

Primary Objective To compare tacrolimus dosing of the new Envarsus®-based immunosuppressive regimen with current clinical practice over 6 months following de novo renal transplantation in a real-life setting in different European Countries.…

Follow-up Protocol to the Double-Blind Parts A and B of the Phase II Opsona Study OPN305-102 (A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN-305, a Humanised Monoclonal Antibody that Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft Function)

To assess out to one-year the clinical status of patients who completed the double-blind part B of the 6-month study period in the Opsona phase II protocol (OPN305-102) by recording the following:• Incidence of biopsy-proven allograft rejection or…

Integrated Overactive Bladder Clinical Trial in clinical practice III

Primary objectives of INTACT III are:1) to prospectively compare the efficacy of Sacral Nerve Stimulation (SNS) with BOTOX® 100 U related to the Patient Perception of Bladder Condition (PPBC) questionnaire (Coyne 2006) and the reduction of urinary…

A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN305, a Humanised Monoclonal Antibody that Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft Function

Primary Objectives:*Phase 0: To determine the receptor occupancy of OPN-305 1.5mg/kg in patients receiving an ECD, DCD or SCD(CIT>18h) kidney transplantation and to verify the doses of OPN-305 to be used in Part A of the study.*Part A: to…

A randomized controlled trial comparing deep versus moderate neuromuscular block - in low pressure pneumoperitoneum - to optimize the surgical conditions during laparoscopic donor nephrectomy

To investigate whether the use of deep neuromuscular block improves surgical conditions in low pressure laparoscopic donor nephrectomy

Randomized Phase III trial comparing immediate versus deferred nephrectomy in
patients with synchronous metastatic renal cell carcinoma.
EORTC 30073 SURTIME

The principal objective of the trial is to investigate whether the sequence of the nephrectomy in patients who receive sunitinib has an effect on patient outcome.

Catheterbased REnal SympatheCtomy for hypErteNsion after kidneyTranplantation

To test the efficacy of renal sympathetic denervation therapy with a special focus on preservation of renal allograft function.

A single centre, prospective, randomised, double-blind, placebo controlled,
sequential, dose-escalating phase I study to assess the safety and tolerability of intravenously infused single doses of OPN-305 in healthy subjects.

Primary : - to assess the safety and tolerability of a single ascending intravenous iv infused doses of OPN-305 in healthy subjects- determination of dose and infusion time for Phase II studiesSecondary : - to determine the pharmacokinetic profile…

Pilot Study of BB3 to Improve Renal Function in Patients with Signs and Symptoms of Significant Renal Injury after Kidney Transplantation from Donors after Cardiac Death

To evaluate the safety and activity of BB3 compared to placebo in improving renal function in the immediate post-transplant period in patientswho have received a DCD kidney transplantation.

Preconditioning of living donor kidneytransplant candidates

The primary objective of this study is to investigate the feasibility of an exercise program of 8 weeks prior to kidneytransplantation. This study also researches the effect of the exercise program on postoperatieve recovery (hospital stay,…

Pilot Study of BB3 to Improve Renal Function in Patients with Signs and Symptoms of Significant Renal Injury after Kidney Transplantation from Donors after Cardiac Death.

To evaluate the safety and activity of BB3 compared to placebo in improving renal function in the immediate post-transplant period in patients who have received a DCD kidney transplantation.

A randomized controlled trial to evaluate the effect on pelvic floor function of pelvic physiotherapy following radical hysterectomy in early stage cervical cancer.

To find out whether pelvic physiotherapy added to an information folder describing pelvic exercises, as is the standard post-operative policy, gives an improved pelvic related quality of life compared to patients receiving the folder only.

A PROSPECTIVE RANDOMIZED STUDY ON THE EFFICACY AND SAFETY OF THE PROPHYLACTIC USE OF RITUXIMAB, ADDED TO STANDARD IMMUNOSUPPRESSIVE TREATMENT IN COMPARISON WITH STANDARD IMMUNOSUPPRESSIVE TREATMENT ALONE IN RENAL TRANSPLANTATION

To determine the effect of rituximab, when added to standard immunsuppressive therapy, on the incidence and severity of biopsy-confirmed acute rejection within the first six months after transplantation.

*In house* Pre-implantation Oxygenated Hypothermic Machine Perfusion Reconditioning after Cold Storage versus Cold Storage alone in ECD Kidneys from Brain Dead Donors

Objective of this study is to compare 1-year garft survival after hypothemic machine perfusion with oxygentaed perfusion solution versus static cold storage of extended criteria kidneys from DBD donors.

A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant

1. To determine the efficacy of QPI-1002 to reduce the incidence and severity of delayed graft function in comparison to placebo in recipients of a donation after brain death (DBD) older donor kidney.2. To assess the safety and tolerability of QPI-…

Alkaline Phosphatase to prevent ischemia reperfusion injury in living kidney transplantation

To study the potential of alkaline phosphatase to protect against ischemia-reperfusion injury in living donor kidney transplantation.

Omission of stent placement on ileal urinary conduit

To assess whether the omission of IOS placement in patients undergoing cystectomy and ileal urinary conduit results in a similar per patient event-free 30-day survival rate as compared to those who receive regular IOS placement.

Lymphadenectomy in urothelial carcinoma in the renal pelvis and ureter - A randomized international clinical trial on lymphadenectomy in urothelial carcinoma in the renal pelvis and ureter

Hypothesis: Complete lymphadenectomy during nephroureterectomy because of invasive urothelial carcinoma may reduce the incidence of lymph nodes metastasis, local recurrence, and distant metastasis and improve the cancer survival rate.Purpose: To…