Vědecká činnost

Grantové aktivity 2010

IGA MZ ČR : NS10590-3/2009:

Kardiovaskulární postižení u nemocných s chronickým onemocněním ledvin.

Řešitelé: Malík J., Holaj R., Tuka V., Chytilová E., Polakovič V., Danzig V.

Klinické studie (zahraniční spolupráce) 2009 

Studie zadané pracovišti zahraničními firmami

HN018/HBV-004: A phase III, multicentric, controlled, randomised, open study comparing the immunogenicity, reactogenicity and safety of Henogen’s new adjuvanted hepatitis B vaccine, HB-AS02V, to that of Aventis Pasteur MSD’s hepatitis B vaccine, HBvax PROR, administered as a booster dose in pre-dialysis, peritoneal dialysis and haemodialysis subjects (≥15 years of age) who previously responded to hepatitis B primary vaccination but lost antibody.

BONAFIDE: Bone Histomorphometry Assessment For Dialysis Patients with Secondary Hyperparathyreoidism of End Stage Renal Disease

STABIL: National study with CERA for maintenance of hemoglobin level in dialysis patients. A single arm, open label study to assess the efficacy, safety and tolerabillity of once-monthly administration of intravenous C.E.R.A. for the maintenance of heamoglobinlevels in dialysis patients with chronic renal anemia.

PRIMO I Study: Paricalcitol Capsules benefits in Renal failure Induced cardiac Morbidity in Subjects with Chronic Kidney Disease Stage 3B/4 : This is a Phase 3, randomized, double-blind, placebo-controlled study investigating the effects of paricalcitol capsules on changes in cardiac structure and function over 48 weeks in subjects with Stage 3B/4 Chronic Kidney Disease (CKD) who have left ventricular hypertrophy (LVH).

PRIMO II Study: Paricalcitol Injection benefits in Renal failure Induced cardiac Morbidity in Subjects with Chronic Kidney Disease Stage 5 : This is a Phase 3, randomized, double-blind, placebo-controlled study investigating the effects of paricalcitol injection on changes in cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have left ventricular hypertrophy (LVH).

MCI-196 E07: A Phase III, Randomised, Double-blind, Multi-centre, Withdrawal Study comparing MCI-196 versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis with Hyperphosphataemia (Incorporating a Randomised 12 Week Open-label Dose Titration Period with MCI-196 or Sevelamer)

MCI-196 E10: A phase III, Multicntre, Open label, Flexible dose, Long term safety study of MCI-196 MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis with Hyperphosphataemia (incorporating comparison with Sevelamer)

BH 21260: A randomized, controlled, open-label, multi-centre, parallelgroup study to assess all-case mortality and cardiovascular morbidity in patients with chronic kidney disease on dialysis and those not on renal replacement therapy under treatment with MIRCERA or reference ESAs

ACT 402: Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride in Haemodialysis patients with Hyperphosphataemia

Darbepoetin alfa: Multicentricka, randomizovana, dvojitě zaslepene klinické hodnoceni porovnávající de novo podávání připravku darbopoetin alfa 1xměsičně s dávkováním 1x za 2 týdny k úpravě anemie u pacientů s chronickým onemocněním ledvin, kteří nepodstupují dialyzu.

Klinické studie (zahraniční spolupráce) 2008

Studie zadané pracovišti zahraničními firmami:

AURORA: A double-blind, randomised. multicentre, phase IIIb, parallel-group study to compare the effects or rosuvastin (10mg oral) with placebo on assessment of survial and cardiovascular events when given to subjects with end-stage renal failure (phase IIIb)

HN018/HBV-004: A phase III, multicentric, controlled, randomised, open study comparing the immunogenicity, reactogenicity and safety of Henogen’s new adjuvanted hepatitis B vaccine, HB-AS02V, to that of Aventis Pasteur MSD’s hepatitis B vaccine, HBvax PRO®, administered as a booster dose in pre-dialysis, peritoneal dialysis and haemodialysis subjects ( 15 years of age) who previously

responded to hepatitis B primary vaccination but lost antibody.

BONAFIDE: Bone Histomorphometry Assessment For Dialysis Patients with Secondary Hyperparathyreoidism of End Stage Renal Disease

STABIL: National study with CERA for maintenance of hemoglobin level in dialysis patients. A single arm, open label study to assess the efficacy, safety and tolerabillity of once-monthly administration of intavenous C.E.R.A. for the maintenance of heamoglobinlevels in dialysis patients with chronic ren al anemia.

PRIMO I Study: Paricalcitol Capsules benefits in Renal failure Induced cardiac Morbidity in Subjects with Chronic Kidney Disease Stage 3B/4 : This is a Phase 3, randomized, double-blind, placebo-controlled study investigating the effects of paricalcitol capsules on changes in cardiac structure and function over 48 weeks in subjects with Stage 3B/4 Chronic Kidney Disease (CKD) who have left ventricular

hypertrophy (LVH).

PRIMO II Study: Paricalcitol Injection benefits in Renal failure Induced cardiac Morbidity in Subjects with Chronic Kidney Disease Stage 5 : This is a Phase 3, randomized, double-blind, placebo-controlled study investigating the effects of paricalcitol injection on changes in cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who

have left ventricular hypertrophy (LVH).

MCI-196 E07: A Phase III, Randomised, Double-blind, Multi-centre, Withdrawal Study comparing MCI-196 versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis with Hyperphosphataemia (Incorporating a Randomised 12 Week Open-label Dose Titration Period with MCI-196 or Sevelamer)

Postery

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Výsledky vyšetření hemodialyzovaných nemocných s pokročilými vaskulárními změnami dolních končetin

Dialyzační koncentrát Citrasate - závěrečná zpráva

In vitro testy a výsledky použití koncentrátu Citrasate při in vivo bikarbonátové hemodialýze a on-line hemodiafiltraci.
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