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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 phase IV, blinded, randomized controlled trial to compare the effectiveness of low pressure pneumoperitoneum during laparoscopic donor nephrectomy to optimize the quality-of-recovery during the early post-operative phase

To investigate whether the use of low pressure pneumoperitoneum during laparoscopic donor nephrectomy improves the quality-of-recovery during the early post-operative phase as compared to the use of standard pressure pneumoperitoneum.

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.

Urethral suspension using vas deferens for prevention of urine incontinence after robot-assisted laparoscopic prostatectomy (RALP)

Improve postoperative urine continence after prostatectomy for prostate cancer.

Low pressure pneumoperitoneum during laparoscopic donornephrectomy: a pilot study

The feasability of a randomized trial studying the advantageous effects of low-pressure pneumoperitoneum during laparoscopic donornephrectomy will be assessed.

Effect of deep neuromuscular block and variations in arterial PCO2 on the surgical rating scale, extubation conditions and postoperative conditions following reversal with sugammadex

To assess whether the implementation of a deep neuromuscular block (NMB) (PTC 1-2) combined with induction of relative hypocapnia creates optimal surgical conditions as measured by the surgeon (using the 5-point Leiden surgical rating scale) versus…

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.