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The effectiveness of tailored E-health self-management treatment for patients with end-stage renal disease: A randomized controlled trial

The overall aim is to assess the effectiveness of guided E-health self-management treatment that is tailored to the individual patient in patients with end-stage renal disease treated by dialysis.

Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

The aim of the research is to determine the effect of GZ/SAR402671 on the total growth in kidney volume (total kidney volume, TKV) in patients with ADPKD. This research also looks at the effectiveness of GZ / SAR402671 in slowing down the decrease…

Effect of High-volume Online hemodiafiLtration on intra-diaLytic hemodynAmic (iN)sTability and cardiac function in chronic hemodialysis patients (the HOLLANT study)

This study aims at improving the knowledge concerning HV-HDF and thus helps to tailor the optimal ERRT for each individual patient.The following hypotheses will be tested:1. Intra-dialytic hemodynamic stability is better preserved during HV-HDF as…

A Phase 2 Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of DCR-PHXC Solution for Injection (subcutaneous use) in Patients with Primary Hyperoxaluria

Primary:To assess the efficacy of DCR-PHXC in reducing urinary oxalate burden in patients with PH (types 1 and 2)Key Secondary:To assess the efficacy of DCR-PHXC in reducing urinary oxalate burden over time in patients with PHSecondary:1. To…

Pharmacokinetic and pharmacodynamic target attainment of ceftazidime in adult patients on general wards with different degrees of renal function: a prospective observational cohort study

To investigate whether the PK-PD target of ceftazidime (50%T>MIC) is attained in the first 24 hours of treatment in adult patients on general wards with adequate and impaired renal function receiving regular and reduced doses of ceftazidime.

A phase III double-blind, randomized study to evaluate the long-term
efficacy and safety of Oxabact® in patients with primary hyperoxaluria

Primary:- To evaluate the efficacy of Oxabact® following 52 weeks treatment in patients with maintained kidney function but below the lower limit of the normal range (eGFR < 90 ml/min/1.73 m2) and a total plasma oxalate concentration &gt…

\u201cA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab plus Standard of Care versus Placebo plus Standard of Care in Adult Subjects with Active Lupus Nephritis\u201d (protocol HGS1006-C1121)

* To evaluate the efficacy of belimumab in combination with standard of care in adult subjects with lupus nephritis Class III, IV, or V using the 2003 ISN/RPS criteria. * To assess the safety and tolerability of belimumab plus standard of care…

Long-term outcomes in immunologically low-risk kidney transplant recipients using tacrolimus.
Extension study of: Tacrolimus monotherapy in immunologically low-risk kidney transplant recipients: a pilot randomized-controlled study.

This study has been transitioned to CTIS with ID 2024-513394-42-01 check the CTIS register for the current data. To assess long-term outcomes in low-immunological risk renal transplant patients beyond one year after transplantation using tacrolimus…

A PHASE IB STUDY OF THE SAFETY AND PHARMACOLOGY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) ADMINISTERED WITH IPILIMUMAB, INTERFERON-ALPHA, OR OTHER IMMUNE-MODULATING THERAPIES IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

Primary ObjectivesThe primary objectives for this study are as follows:* To evaluate the safety and tolerability of atezolizumab and ipilimumab when administered in combination in patients with advanced or metastatic non-small cell lung cancer (…

A phase 3 randomized, open-label (sponsor-blind), active-controlled, parallel-group, multi-center, event driven study in dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to recombinant human erythropoietin, following a switch from erythropoietin-stimulating agents.;Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Dialysis (ASCEND-D)

Co-primary (tested in parallel for non-inferiority):- To compare daprodustat to rhEPO for CV safety (non-inferiority)- To compare daprodustat to rhEPO for Hgb efficacy(non-inferiority)

A phase 3 randomized, open-label (sponsor-blind), active-controlled, parallel-group, multi-center, event driven study in non-dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa;Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Non-Dialysis (ASCEND-ND)

Co-primary (tested in parallel for non-inferiority):-To compare daprodustat to darbepoetin alfa for CV safety (non-inferiority)-To compare daprodustat to darbepoetin alfa for Hgb efficacy(non-inferiority)

Phase 2 randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of Reltecimod as compared to placebo in addition to standard of care in patients with sepsis-associated acute kidney injury (SA-AKI)

Primary objective:* To compare the rates of complete recovery (alive, free of dialysis and return of serum creatinine to <150% of reference baseline; equivalent to acute kidney disease (AKD) category 0) at Day 14 between the Reltecimod-…

An international, randomised, open label trial comparing a rituxmab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, 'generalised' ANCA associated vasculitis

To assess the rates of preliminary response and sustained remission of AASV following rituximab (on the basis of former studies, 86% sustained remission expected with rituximab compared to 75% in control group).To assess safety of a rituximab…

Anticoagulation with nadroparin in continuous venovenous hemofiltration (CVVH): extracorporeal clearance and systemic effects of nadroparin

Aim of the present study is to determine · whether and to what extent nadroparin is excreted by CVVH · whether the drug accumulates during CVVH as measured by anti-Xa activity and endogenous thrombine potential (ETP)· whether clearance of nadroparin…

Treatment of vascular stiffness in patients with autosomal dominant polycystic kidney disease

This study has been transitioned to CTIS with ID 2024-512544-27-00 check the CTIS register for the current data. We aim to investigate if arterial stiffness is exacerbated due to a high-salt diet in patients with ADPKD. We also intend to explore…

Model Informed preciSion doSIng tO iNdividualise and optimize pharmacotherapeutic treatment (MISSION) - Appendix 1: Prospective evaluation of Model informed precision dosing (MIPD) for tacrolimus and mycophenolic acid in paediatric patients with a kidney disease

Overall objective:To improve the existing drug prescribing and treatment monitoring process.Objective appendix 1: To prospectively evaluate the predictive performance of the MIPD strategy for tacrolimus and mycophenolic acid in paediatric patients…

Near-infrared fluorescence imaging in kidney transplantations using ZW800-1 for perfusion assessment: a pilot study

To assess the feasibility of ZW800-1 in the intraoperative assessment of kidney and ureter perfusion during kidney transplantations (living donor nephrectomy and transplantation)

REnal function after PULSatile blood flow during cardiopulmonary bypass in cardiac surgery

Does pulsatile blood flow during cardiopulmonary bypass lead to a reduction in the average increase in postoperative creatinine levels in patients with preoperative renal dysfunction when compared to non-pulsatile blood flow?

A Placebo-Controlled, Single-Blind, Single-Center Phase 1 Study in Normal Healthy Volunteers and Open-Label Multi Center Study in Patients with Primary Hyperoxaluria to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of DCR PHXC Solution for Injection (subcutaneous use)

Objectives:Primary:* To evaluate the safety and tolerability of single doses of DCR-PHXC Solution for Injection (SC use) (*DCR-PHXC*) inNHV (Group A) and in patients with primary hyperoxaluria (PH) (Group B).Secondary:* To characterize the…

promoting Medication AdheRence and Self-management among kidney transplant recipients: a randomized controlled trial (the MARS Trial)

In this project we aim to anticipate the need for effective interventions and develop an outreaching systemic intervention for promoting adherence and self-management among adolescent and adult kidney transplant recipients aged from 12 years. The…