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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…

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…

Effects of oral iron supplementation on the gut microbiome and plasma uremic toxin levels in patients with chronic kidney disease

This study assesses the effect of oral iron supplementation on gut-derived plasma uremic toxin levels in patients with chronic kidney disease (CKD) and with iron deficiency. The main research questions to be answered are:1. Does oral iron…

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…

Discriminating between thalassemias and iron disorders with the Laser optical rotational cell analyser (Lorca).

Assessing different modalities of ektacytometry in diagnosing thalassemia and/or iron disorders. Investigating the influence of hemoglobinopathies and iron disorders on red cell membrane deformability in comoparison with healthy controls.