18 results
The objective of this study is to compare the overall survival of patients with prostate cancer who are no longer responding to hormone therapy (castration resistant) and who have not yet received chemotherapy live longer (overall survival) when…
The aims of the current study are two-fold. First we will investigate whether a CYP3A5 genotype-based tacrolimus dosing strategy will result in improved clinical outcomes as compared with a standard tacrolimus dosing regimen based on bodyweight.…
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…
The aim of this study is to investigate if conversion of tacrolimus-based immunosuppression to everolimus-based immunosuppression results in preservation of renal function as compared to continued tacrolimus-based immunosuppression. Apart from renal…
To compare in a prospective randomised way the effect of two different immunosuppressive regimens - mTOR-based regimen or CNI-based regimen - on the progression of coronary artery calcification in renal transplant patients measured at baseline, 1, 2…
To evaluate the use of concentration-controlled everolimus, with the reduction or the elimination of tacrolimus, to provide superior renal function and to provide non-inferior rates of the composite efficacy endpoint compared to the tacrolimus…
Aim of the study is to evaluate RPL554*s safety in healthy, non-asthmatic subjects and consequently to assess RPL 554 safety and efficacy in allergic asthmatics and in allergic rhinitics.
To eassess the effect of a switch in immunosuppressive regimen and dosing regimen on renal function, blood pressure and laboratory parameters.To assess the effect on renal function, blood pressue and laboratory parameters of a switc from tacrolimus…
Primary objective:To assess the safety of nebulised RPL554 at 2 single, ascending, inhaled doses of 0.036 mg/kg (12X) and 0.072 mg/kg (24X) in allergic asthmatics using standard safety measures with intensive monitoring of any potential…
To evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients at Month 36 post-transplantation.
To evaluate the urodynamic effects, the safety and tolerability and the clinical efficacy of AV608 compared with placebo in subjects with idiopathic detrusor overactivity
PRINCIPAL OBJECTIVE To evaluate whether sequential therapy with tacrolimus for 9 months (6 months of full therapy and 3 months of tapering doses) followed by a dose of RTX leads to a greater increase in the proportion of primary MN patients with…
The main objective of the study is to demonstrate the utility and safetyof the IFN-γ ELISPOT marker for the stratification of kidney transplantrecipients into low and high IS regimens. The enrichment study will testnon-inferiority of low IS regimen…
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…
Primary To confirm superiority on body weight reduction of CagriSema 2.4 mg/2.4 mg versus placebo as adjuncts to reduced-calorie diet andincreased physical activity in participants with overweight or obesity. Secondary To confirm superiority of…
Primary Objective: To investigate the kinetics of the anti-viral effects of VCS, compared to standard of care with TAC, on SARS-CoV-2 over 56 days, in stable KTRs.Secondary Objective: To assess the safety and tolerability of VCS in stable KTRs…
Primary: to confirm non-inferiority of CagriSema 2.4 mg/2.4 mg versus placebo with respect to time to first major adverse cardiovascular event (MACE). Secondary: to confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo with respect to time…
The main objective of this trial is to investigate glucagon receptor occupancy of BI 456906 in the liver with PET imaging using the radiolabeled tracer [68Ga]Ga-DO3A-VS-Cys40-Tuna-2.The secondary objectives is to investigate the GLP-1 receptor…