- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02055482
Long-term Pre-dialysis Extension in Europe and Asia Pacific (DIALOGUE 3)
A Controlled, Parallel Group, Open-label, Multicenter Extension Study to Investigate Efficacy and Safety of Oral BAY85-3934 and Darbepoetin Alfa Comparator in the Long Term Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease in Europe and Asia Pacific
Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin.
The purpose of this extension study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease.
The extension study will enroll up to 240 patients at multiple locations in Europe, Asia and Australia. Patients who participated in Studies 15141 or 15261 may be eligible to take part in the extension study. The study consists of the Haemoglobin (Hb) Stabilisation Phase and the Main Phase. The Hb Stabilisation Phase involves up to 10 study visits scheduled over 16 weeks. The Main Phase will last for at least 6 months and up to a maximum of 36 months, with visits every 4 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests.
The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this research. This study will include subjects who either completed the treatment period in their respective Phase 2 parent study (i.e., Study 15141 or Study 15261) or experienced a stopping event in the fixed dose parent study (Study 15141). As Study 15141 is a double-blind study, subjects will be unblinded as per the Study 15141 protocol prior to entry into the extension study.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
-
Reservoir, Australien, 3073
-
-
New South Wales
-
Gosford, New South Wales, Australien, 2250
-
-
Victoria
-
Melbourne, Victoria, Australien, 3052
-
-
-
-
-
Burgas, Bulgarien, 8000
-
Dobrich, Bulgarien, 9300
-
Gabrovo, Bulgarien, 5300
-
Karlovo, Bulgarien, 4300
-
Lovech, Bulgarien, 5500
-
Montana, Bulgarien, 3400
-
Pazardjik, Bulgarien, 4400
-
Sofia, Bulgarien, 1431
-
Sofia, Bulgarien, 1527
-
Sofia, Bulgarien, 1309
-
Sofia, Bulgarien, 1872
-
Stara Zagora, Bulgarien, 6000
-
Veliko Tarnovo, Bulgarien, 5000
-
-
-
-
-
Chorley, Det Forenede Kongerige, PR7 7NA
-
Glasgow, Det Forenede Kongerige, G20 OSP
-
Liverpool, Det Forenede Kongerige, L7 8XP
-
Liverpool, Det Forenede Kongerige, L22 0LG
-
London, Det Forenede Kongerige
-
London, Det Forenede Kongerige, SE5 9RS
-
Manchester, Det Forenede Kongerige, M15 6SX
-
-
Berkshire
-
Reading, Berkshire, Det Forenede Kongerige, RG2 0TG
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 0QQ
-
-
Dundee City
-
Dundee, Dundee City, Det Forenede Kongerige, DD1 9SY
-
-
East Sussex
-
Brighton, East Sussex, Det Forenede Kongerige, BN2 5BE
-
-
Manchester
-
Salford, Manchester, Det Forenede Kongerige, M5 5AP
-
-
Northumberland
-
Hexham, Northumberland, Det Forenede Kongerige, NE46 1QJ
-
-
South Yorkshire
-
Doncaster, South Yorkshire, Det Forenede Kongerige, DN2 5LT
-
-
West Yorkshire
-
Leeds, West Yorkshire, Det Forenede Kongerige, WF3 4PX
-
-
-
-
-
Brest Cedex, Frankrig, 29609
-
Grenoble Cedex 9, Frankrig, 38043
-
Limoges Cedex1, Frankrig, 87042
-
Pierre Benite Cedex, Frankrig, 69495
-
Valenciennes, Frankrig, 59300
-
-
-
-
-
Ashkelon, Israel, 7827804
-
Hadera, Israel, 3810101
-
Jerusalem, Israel, 9112001
-
Kfar Saba, Israel, 4428164
-
Nahariya, Israel, 2210001
-
-
-
-
Abruzzo
-
Chieti, Abruzzo, Italien, 66013
-
-
Campania
-
Napoli, Campania, Italien, 80138
-
-
Emilia-Romagna
-
Modena, Emilia-Romagna, Italien, 41100
-
-
Lombardia
-
Brescia, Lombardia, Italien, 25123
-
Cremona, Lombardia, Italien, 26100
-
Lecco, Lombardia, Italien, 23900
-
Milano, Lombardia, Italien, 20132
-
Milano, Lombardia, Italien, 20162
-
Pavia, Lombardia, Italien, 27100
-
-
Toscana
-
Livorno, Toscana, Italien, 57023
-
-
-
-
-
Chiba, Japan, 260-8712
-
Fukuoka, Japan, 810-8563
-
Nagano, Japan, 388-8004
-
Nara, Japan, 631-0846
-
-
Fukuoka
-
Kitakyushu, Fukuoka, Japan, 802-8555
-
Okawa, Fukuoka, Japan, 831-0016
-
-
Hokkaido
-
Muroran, Hokkaido, Japan, 050-0083
-
-
Ishikawa
-
Hakusan, Ishikawa, Japan, 924-8588
-
-
Iwate
-
Morioka, Iwate, Japan, 020-0066
-
-
Kanagawa
-
Fujisawa, Kanagawa, Japan, 251-8550
-
Kamakura, Kanagawa, Japan, 247-8533
-
-
Mie
-
Kuwana, Mie, Japan, 511-0061
-
-
-
-
-
Ankara, Kalkun, 06100
- Ankara Univ. Medical Faculty
-
Ankara, Kalkun, 06490
- Baskent University Medical Faculty
-
Izmir, Kalkun, 03540
- Sifa University Medical Faculty
-
-
-
-
-
Seoul, Korea, Republikken, 156-755
-
Seoul, Korea, Republikken, 03080
-
Seoul, Korea, Republikken, 156-707
-
-
Gyeonggido
-
Bucheon-si, Gyeonggido, Korea, Republikken, 420-767
-
-
-
-
-
Bialystok, Polen, 15-540
-
Poznan, Polen, 61-858
-
Radom, Polen, 26-610
-
Szczecin, Polen, 70-111
-
Zyrardow, Polen, 96-300
-
-
-
-
-
Brasov, Rumænien, 500152
-
Bucharest, Rumænien, 010731
-
Bucharest, Rumænien, 020475
-
Bucharest, Rumænien, 050098
-
Constanta, Rumænien, 900591
-
Oradea, Rumænien, 410469
-
Targu-Mures, Rumænien, 540103
-
-
-
-
-
Alicante, Spanien, 03010
-
Barcelona, Spanien, 08036
-
Barcelona, Spanien, 08035
-
Córdoba, Spanien, 14004
-
Madrid, Spanien, 28041
-
Madrid, Spanien, 28007
-
-
A Coruña
-
Santiago de Compostela, A Coruña, Spanien, 15706
-
-
Barcelona
-
L'Hospitalet de Llobregat, Barcelona, Spanien, 08907
-
-
Madrid
-
San Sebastián de los Reyes, Madrid, Spanien, 28702
-
-
-
-
-
Berlin, Tyskland, 12053
-
Wuppertal, Tyskland, 42283
-
-
Baden-Württemberg
-
Pirmasens, Baden-Württemberg, Tyskland, 66953
-
Villingen-Schwenningen, Baden-Württemberg, Tyskland, 78052
-
-
Nordrhein-Westfalen
-
Bonn, Nordrhein-Westfalen, Tyskland, 53127
-
Düsseldorf, Nordrhein-Westfalen, Tyskland, 40210
-
-
Sachsen-Anhalt
-
Halle (Saale), Sachsen-Anhalt, Tyskland, 06097
-
-
-
-
-
Baja, Ungarn, 6500
-
Budapest, Ungarn, 1036
-
Debrecen, Ungarn, 4032
-
Esztergom, Ungarn, 2500
-
Kaposvar, Ungarn, 7400
-
Pecs, Ungarn, 7624
-
Szigetvar, Ungarn, 7900
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Men who agree to use adequate contraception when sexually active or women without childbearing potential
- Not on dialysis at study entry
- Serum ferritin levels ≥ 100 μg/L and < 1000 μg/L or transferrin saturation ≥ 20%
- Inclusion criteria for inclusion into the Hb Stabilization (HbS) Phase: Requires Hb stabilization (at 10.0 to 12..0g/dL for a minimum of 4 weeks) as follows: Received BAY 85-3934 and reached a stopping event in Study 15141 or received placebo and reached a stopping event in Study 15141 or completed 16 weeks of treatment with BAY 85-3934 in Study 15141or 15261 but had mean Hb during the evaluation period outside the target range of 10.0 to 12.0 g/dL, or Completed 16 weeks of treatment with placebo in Study 15141 and was re-assessed at 4 weeks after end of study as eligible for Study 15653 (this study)
- Inclusion criteria for inclusion into the Main Phase: Mean Hb concentration of 10.0 to 12.0 g/dL who completed 16 weeks of treatment (BAY85-3934 arm) in Study 15141, or completed 16 weeks of treatment (BAY-3934 or darbepoetin arm)in study 15261 without a dose suspension lasting > 6 consecutive weeks, or mean Hb concentration of 10.0 to 12.0g/dL during the HbS phase of Study 15653 for a minimum of 4 weeks after visit 3.
Exclusion Criteria:
- A scheduled kidney transplant or any other organ transplant within the next 6 months (being on a waiting list does not exclude the subject)
- Red blood cell (RBC) containing transfusion within the 8 weeks before baseline
- Phosphodiesterase type 5 (PDE5) inhibitor (e.g., sildenafil, vardenafil, tadalafil) or nitrates
- Sustained, poorly controlled arterial hypertension or hypotension at baseline, defined as blood pressure ≥ 180/110 mmHg or systolic blood pressure < 95 mmHg, respectively
- Severe rhythm or conduction disorders (e.g., heart rate [HR] < 50 or > 110 bpm, atrial flutter, prolonged QT > 500 msec, second or third degree atrioventricular [AV] block), if not reacted with a pace marker)
- New York Heart Association Class III or IV congestive heart failure
- Severe hepatic insufficiency (defined as alanine aminotransferase [ALT], aspartate aminotransferase [AST]>3x the upper limit of normal [ULN], total bilirubin > 2 mg/dL, or Child Pugh B or C) or active hepatitis, in the investigator's opinion
- An ongoing serious adverse event (SAE) from Study 15141 or Study 15261 that is assessed as related to study drug
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: BAY85-3934
|
BAY85-3934 will be titrated at the scheduled dose control visits to maintain the Hb in the target range of 10.0 to 12.0 g/dL.
Available doses include 15, 25, 50, 75, 100, and 150 mg/day OD.
Treatment will be for minimum of 6 months to up to a maximum of 36 months.
|
Aktiv komparator: Darbepoetin
|
Darbepoetin will be administered according to the local label and titrated at the scheduled dose by intravenous injection.
Treatment will be for a minimum of 6 months to up to a maximum of 36 months.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Ændring i lokalt laboratoriehæmoglobinniveau fra baseline
Tidsramme: Baseline op til 36 måneder
|
Baseline op til 36 måneder
|
Number of participants with serious adverse events (SAEs) and adjucated adverse events as a measure of safety and tolerability
Tidsramme: Up to 36 months
|
Up to 36 months
|
Number of participants with liver function-related AEs including abnormal liver function tests and any hospitalization
Tidsramme: Up to 36 months
|
Up to 36 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Varighed af behandlingseksponering
Tidsramme: Op til 36 måneder
|
Op til 36 måneder
|
Antal forsøgspersoner, der kræver titrering af dosis
Tidsramme: Op til 36 måneder
|
Op til 36 måneder
|
Ændring af retikulocyttal fra denne undersøgelses baseline
Tidsramme: Baseline op til 36 måneder
|
Baseline op til 36 måneder
|
Ændring af antallet af røde blodlegemer fra denne undersøgelses baseline
Tidsramme: Baseline op til 36 måneder
|
Baseline op til 36 måneder
|
Ændring af hæmatokrit fra denne undersøgelses baseline
Tidsramme: Baseline op til 36 måneder
|
Baseline op til 36 måneder
|
Ændring af det centrale laboratoriehæmoglobinniveau fra denne undersøgelses baseline
Tidsramme: Baseline op til 36 måneder
|
Baseline op til 36 måneder
|
Time within hemoglobin target range (10.0 to 12.0 g/dL)
Tidsramme: Up to 36 months
|
Up to 36 months
|
Responders in Hb levels
Tidsramme: Up to 36 months
|
Up to 36 months
|
Number of subjects meeting specific Hb criteria
Tidsramme: Baseline up to 36 months
|
Baseline up to 36 months
|
Number of subjects with Hb values >13 g/dL or having excessive Hb increase
Tidsramme: Baseline up to 36 months
|
Baseline up to 36 months
|
Number of participants with non-serious adverse events
Tidsramme: Up to 36 months
|
Up to 36 months
|
Change in heart rate (HR)
Tidsramme: Up to 36 months
|
Up to 36 months
|
Change in blood pressure (BP)
Tidsramme: Up to 36 months
|
Up to 36 months
|
Laboratory abnormalities
Tidsramme: Up to 36 months
|
Up to 36 months
|
Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
Change of reticulocyte count from baseline of study 15141 or 15261
Tidsramme: Baseline up to 36 months
|
Baseline up to 36 months
|
Change of red blood cell count from baseline of study 15141 or 15261
Tidsramme: Baseline up to 36 months
|
Baseline up to 36 months
|
Change of hematocrit from baseline of study 15141 or 15261
Tidsramme: Baseline up to 36 months
|
Baseline up to 36 months
|
Change of central laboratory hemoglobin level from baseline of study 15141 or 15261
Tidsramme: Baseline up to 36 months
|
Baseline up to 36 months
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 15653
- 2013-001190-24 (EudraCT nummer)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Nyreinsufficiens, kronisk
-
Jules Bordet InstituteMacopharma; Belgian Hematological SocietyRekrutteringRefractory Chronic Graft Versus Host Disease (cGVHD)Belgien
-
Universitaire Ziekenhuizen KU LeuvenAfsluttetForekomst af Augmented Renal Clearance | Risikofaktorer for øget renal clearanceBelgien
-
Medical University of ViennaAfsluttetGlomerulær filtreringshastighed | Fedtsyrer, ikke-esterificerede | Renal Cirkulation | Renal Plasma FlowØstrig
-
The First People's Hospital of ChangzhouIkke rekrutterer endnu
-
Hospices Civils de LyonAfsluttetSkadelig virkning | Renal toksicitetFrankrig
-
Andrew B AdamsBristol-Myers SquibbAfsluttet
-
National Cancer Institute (NCI)AfsluttetLunge | Bryst | Ovarie | Cervikal | RenalForenede Stater
-
University Health Network, TorontoAfsluttetGlomerulær filtreringshastighed | Renal blodgennemstrømningCanada
-
Assiut UniversityIkke rekrutterer endnuLevertransplantation; Komplikationer | Renal komplikation af proceduren
Kliniske forsøg med Molidustat (BAY85-3934)
-
BayerAfsluttetNyreinsufficiens, kroniskTyskland
-
BayerAfsluttetNyreinsufficiens, kronisk | AnæmiJapan
-
BayerAfsluttetNyreinsufficiens, kronisk | AnæmiForenede Stater, Japan
-
BayerAfsluttetNyreinsufficiens, kronisk | AnæmiJapan
-
BayerAfsluttetNyreinsufficiens, kronisk | AnæmiJapan
-
BayerAfsluttetNyreinsufficiens, kronisk | AnæmiJapan
-
BayerAfsluttet
-
BayerAfsluttetAnæmiTyskland, Det Forenede Kongerige