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A 24 month, multicenter, randomized, open-label safety and efficacy study of concentration-controlled everolimus with reduced calcineurin inhibitor vs mycophenolate with standard calcineurin inhibitor in de novo renal transplantation- Advancing renal TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen (TRANSFORM)

Primary: to evaluate the effect of everolimus with reduced exposure CNI versus MPA with standard exposure CNI on the binary composite of treated biopsy-proven acute rejection (tBPAR) or eGFR < 50mL/min/1.73m2 at Month 12 post-transplantation.…

Cardiovascular (CV) risk prediction and CV biomarkers in renal transplant recipients treated with belatacept compared to calcineurin inhibitors (CNI).;Open randomized 12 month study.

The goal of this study is to prove whether kidney transplant recipients can reduce their risk of cardiovascular disease bij converting to Nulojix.

Effects of dietary sodium restriction on blood pressure in renal transplant recipients: an intervention study

Primary Objective: •To investigate the effect of dietary sodium restriction on blood pressure and use of antihypertensive medication in renal transplant recipients.Secondary Objective(s): •To investigate the effect of dietary sodium restriction on…

Prevention of peritonitis in patients with peritoneal dialysis -
effects of regular follow-up of patients* theoretical knowledge and practical skills with focus on infection prophylaxis

To study if regular follow-up of PD patients with testing of their theoretical and practical knowledge (hereafter called *new type of follow-up*) can reduce the incidence of peritonitis, reduce the technique failure rate related to peritonitis, and…

Immunological monitoring of VZV vaccination in patients with renal failure versus healthy individuals

To study if there is a role for prophylactic VZV vaccination prior to transplantation to boost the patients B- and T-cell repertoire and thereby reducing the incidence and morbidity associated with herpes zoster.

Autologous BM derived MSCs in combination with everolimus to preserve renal structure and function in renal recipients

A 6-month study of efficacy and safety comparing concentration-controlled Certican® with MSCs to Certican® with standard tacrolimus in renal transplant recipients

A multi-center, randomized, controlled trial with programmed introduction of Sirolimus-based, Calcineurin inhibitor free immunosuppression in recipients of non-heart-beating donor kidney grafts.

To investigate the safety and efficacy of a programmed introduction of a sirolimus based calcineurin inhibitor free maintenance immunosuppressive regime three months after renal transplantation in recipients of a non-heart-beating donor kidney graft…

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,…

ADMA and renal endothelial dysfunction: de effects of ARB and/or statins in hypertensive patients with mild renal insufficiency

The results of this study will give better insights in the role of ADMA in the development of systemicendothelial dysfunction and the relation with mild renal insufficiency.

Nephro-Urological evaluation of a National Prenatal Ultrasound Screening Program of the Fetus

Objective of this study is the development of a national "best practice guideline on pre and postnatal follow up for prenatally detected abnormalities of the kidney and/or urinary tract". Furthermore, the guidelijne will be evaluated and…

Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mortality.

The aim of this study is to evaluate if IV albumin administration improves short-term survival in patients with advanced cirrhosis (serum creatinine * 1.2 mg/dl, serum sodium * 130 mEq/l and/or serum bilirubin *4 mg/dl), signs of systemic…

A 12-month, open-label, multicenter, randomized, safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) study of two regimens of anti-CD40 monoclonal antibody, CFZ533 vs. standard of care control, in adult de novo liver transplant recipients with a 12-month additional follow-up and a long-term extension (CONTRAIL I).

This study will allow the assessment of the ability of CFZ533 to replace calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing potentially better renal function with an expected similar safety and tolerability profile.…

A partially-blinded, active-controlled, multicenter, randomized study evaluating efficacy, safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) of an anti-CD40 monoclonal antibody, CFZ533, in de novo and maintenance kidney transplant recipients (CIRRUS I, CCFZ553A2201)

Primary Objective(s) (Cohort 1):* To demonstrate that CFZ533 600 mg and/or 300 mg bi-weekly (Q2W), subcutaneous (SC), is non-inferior to a tacrolimus-based regimen with respect to the proportion of patients who experience composite efficacy failure…

The effect of proactive versus reactive treatment of hypotension on postoperative disability and outcome in surgical patients under anesthesia (PRETREAT): an adaptive, multicenter randomized controlled trial

The aim of this adaptive multicentre randomized controlled trial is to maintain patients at a target blood pressure level with a sufficient margin from the minimal acceptable blood pressure threshold of a MAP of 65 mmHg to reduce the incidence of…

A 12-month randomized, multiple dose, open-label, study evaluating safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of an anti-CD40 monoclonal antibody, CFZ533, in combination with mycophenolate mofetil (MMF) and corticosteroids (CS), with and without tacrolimus (Tac), in de novo renal transplant recipients

Primary:Part 1: PK, PD and SafetyTo assess the safety, tolerability and pharmacokinetics of multiple IV and SC doses of CFZ533 in combination with MMF, CS, and Tac (standard exposure) in de novo renal transplant patients over the treatment and…