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Number of records: 12
Title of the trial Diagnosis
Phase IIa study to evaluate the safety, pharmacokinetics, and pharmacodynamics of repeated administrations over 4 weeks of the hepcidin antagonist PRS-080#022-DP in anemic chronic kidney disease patients undergoing hemodialysis anemic chronic kidney disease undergoing hemodialysis
Phase 3, randomized, open-label, active-controlled study evaluating the efficacy and safety of oral vadadustat for the maintenance treatment of anemia in subjects with non-dialysis-dependent chronic kidney disease (NDD-CKD) (PRO2TECT-CONVERSION) anemia in subjects with non-dialysis-dependent chronic kidney disease
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 non-dialysis subjects with anemia associated with chronic kidney disease
A Multicenter Single-arm Extension Study to Characterize the Long-termSafety of Cinacalcet Hydrochloride in the Treatment of SecondaryHyperparathyroidism in Pediatric Subjects With Chronic Kidney Disease on Dialysis Chronic Kidney Disease on Dialysis
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of the Safety and Efficacy of Roxadustat in the Treatment of Anemia in Dialysis Patients anemia in dialysis patients
A Multicenter Single-arm Extension Study to Describe the Long-term Safetyof AMG 416 (Velcalcetide) in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis Chronic Kidney Disease on Hemodialysis
An Open-label, Single-arm Study to Assess the Safety and Tolerability of Cinacalcet HCl in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 years with chronic Kidney Disease and Secondary Hyperparathyroidism Receivnig Dialysis in Pediatric Subjects Age 28 Days to < 6 years with chronic Kidney Disease and Secondary Hyperparathyroidism Receivnig Dialysis
A phase III, randomized, assessor-blinded, active-controlled, multicenter study ot the efficacy and safety of APO-EPO as compared to Procrit when given intravenously to patients with anemia and chronic kidney disease stage 5 on hemodialysis, currently not on epoetin replacement therapy. patients with anemia and chronic kidney disease stage 5 on hemodialysis
The IMPACT SHPT Study: Study to evaluate the improved management of iPTH with Paricalcitol-centered therapy vs. cinacalcet therapy with low-dose vitamin D in hemodialysis patients with secondary hyperparathyroidism Hemodialysis patients with secondary hyperparathyroidism
Multi-center, prospective, randomized trial to demonstrate improved metabolic control of p Multi-center, prospective, randomized trial to demonstrate improved metabolic control of PPEN vs DDDD in diabetic caps patients - the IMPENDIA trial. Diabetes with continuos ambul.peritoneal dialysis
An Open, Randomised, Controlled, Parallel Group, Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride in Heamodialysis Patients with Hyperphospataemia haemodialysis patients with hyperfosphataemia
Randomized, controlled, double-blind multicenter safety study to evaluate the safety and immunogenecity of subcutaneous EPO HEXAL vs. ERYPO? in the treatment of anemia associated with chronic renal insufficiency in predialysis patients Chronic Renal Insufficiency in Predialysis Patients
Pursuant to Section 99 par. 1 indent f) (2) of Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals) as amended, the State Institute for Drug Control publishes information about clinical trials approved in the Czech Republic.
Database included clinical trials approved since the effect of the Act on Pharmaceuticals. Information about clinical trials from the year 2004 – 2007 are being supplemented continuously.
Database, according to Act, doesn´t include bioequivalence trials and clinical trials in phase I (i.e. first-in-man trials, the first stage of testing in human subjects).

Glossary of clinical trials terms:
Sponsor = An individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial.
Study code / Protocol number = trial identifying number for sponsor
EudraCT number = EU trial identifying number
Subject = an individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control; patient or healthy volunteer.
MEK = Ethics Committee for Multicentric Clinical Trials
Double-blind study = A clinical trial design in which neither the participating individuals (subjects) nor the study staff knows which participants are receiving the investigational drug and which are receiving a placebo or another therapy.
Randomized trial = A study in which participants/subjects are randomly (i.e. by chance) assigned to one of two or more treatment arms of a clinical trial.
Multicentric trial = a clinical trial conducted according to a single protocol but at more than one site and therefore, carried out by more than one investigator.
Placebo = an inactive pill, liquid, or powder that has no treatment value.
Last database change: 30. September 2023 at 05:10
 

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