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TRIUMPH-2: Trientine dihydrochloride (Syprine® capsules) vs. tetrahydrochloride (tablets): a Phase 1, single center, randomized, interventional, open-label, 4-way crossover study in adult healthy male and female subjects to evaluate the pharmacokinetics and the safety and tolerability of 2 different oral formulations.

The primary objective of this study is to evaluate and compare the plasma PK parameters of TETA and its two metabolites (MAT and DAT) after two dose levels of Syprine® capsules and TETA 4HCL tablets in adult healthy male and female volunteers.The…

Proton pump inhibitors in the prevention of iron reaccumulation in patients with hereditary hemochromatosis

The effectiveness an cost effectiveness of PPIs compared to standard phlebotomy therapy in the prevention of iron overload in patients with hereditary hemochromatosis.

A Randomised, double-blind, controlled trial to evaluate the effects of a micronutrient-fortified Growing Up Milk on the micro-nutrient status of young children

The objective of this study is to investigate the effect of a micronutrient-fortified GUM given for 20 weeks on the iron and vitamin D status of healthy 12-36 month old children in comparison to the control product.

Optimizing iron suppletion after Roux-en-Y Gastric Bypass

Part 1:Prospective evaluation of serum ferritin levels after suppletion with ferrous fumarate, Losferron or Ferinject in patients with iron deficiency after primary RYGB. Which therapy is the most effective one to replace ironstorage?We also analyse…

Optimizing Iron suppletion trial after Roux- en -Y Gastric Bypass

Ferinject in patients with iron deficiency after primary RYGB. Which therapy is the most effective one to replace ironstorage?We also analyse the interval between initiation of therapy and adequate correction of iron deficiency.

An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject® High- and Low-dosage Regimens) versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Subjects with Non-dialysis-dependent Chronic Kidney Disease

* To evaluate the long-term efficacy of FCM (using targeted ferritin levels to determine dosing) or oral iron to delay and/or reduce erythropoiesis stimulating agent (ESA) use and/or other anaemia management options in NDD-CKD subjects with iron…

postoperative intravenous iron injections (Venofer) vs. control in total hip and knee arthroplasty

Evaluate iron metabolism, erythropoiesis and hemoblobin level periooperative in patients treated with postoperative intravenous iron injections compared to controls.

Multicentre, Prospective, Randomised, 2-arm Study to Assess the Impact of Ferric Carboxymaltose on Exercise Capacity in Chronic Heart Failure Patients with
Iron Deficiency

Primary Objectives:• To evaluate the efficacy of intravenous (IV) FCM compared to usual care on exercise capacity.Secondary Objectives:• To evaluate the efficacy of IV FCM compared to usual care on biomarkers for iron deficiency (ID), cardiac…

TRIENTINE DIHYDROCHLORIDE VS. TETRAHYDROCHLORIDE: A PHASE 1, SINGLE CENTER, RANDOMIZED, INTERVENTIONAL, SINGLE DOSE, OPEN-LABEL, CROSSOVER STUDY IN ADULT HEALTHY MALE AND FEMALE SUBJECTS TO EVALUATE THE PHARMACOKINETICS AND THE SAFETY, TOLERABILITY OF TWO DIFFERENT ORAL FORMULATIONS

The principal aim of this study is to evaluate the PK parameters of both oral formulations in adult healthy volunteers in order to propose forMarketing Authorization Application an adequate strength for TETA•4HCl (i.e. a strength providing a PK…

EFFECT OF FERRIC CARBOXYMALTOSE ON EXERCISE CAPACITY AFTER KIDNEY TRANSPLANTATION: A MULTICENTER RANDOMIZED CONTROLLED TRIAL

To study the effects of FCM on exercise tolerance, haematinic parameters, quality of life, cardiac function, muscle function, bone and mineral parameters, microbiota, the immune system, the incidence of infections, allograft failure and mortality in…