Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
17. april 2013 opdateret af: AbbVie (prior sponsor, Abbott)
This study is a comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease patients receiving hemodialysis with secondary hyperparathyroidism.
The main objective of this study is to demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone without clinically significant hypercalcemia, compared to maxacalcitol injection.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
255
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Aichi, Japan
- Site Reference ID/Investigator# 53485
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Chiba, Japan
- Site Reference ID/Investigator# 51571
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Chiba, Japan
- Site Reference ID/Investigator# 52963
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Chiba, Japan
- Site Reference ID/Investigator# 52966
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Gifu, Japan
- Site Reference ID/Investigator# 51578
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Gunma, Japan
- Site Reference ID/Investigator# 52965
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Hadano-City, Japan
- Site Reference ID/Investigator# 53782
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Himeji-City, Japan
- Site Reference ID/Investigator# 57483
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Hokkaido, Japan
- Site Reference ID/Investigator# 57487
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Hyogo, Japan
- Site Reference ID/Investigator# 53484
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Ibaraki, Japan
- Site Reference ID/Investigator# 54385
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Kagawa, Japan
- Site Reference ID/Investigator# 51581
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Kagoshima, Japan
- Site Reference ID/Investigator# 59164
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Kanagawa, Japan
- Site Reference ID/Investigator# 51574
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Kanagawa, Japan
- Site Reference ID/Investigator# 51575
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Kodaira, Japan
- Site Reference ID/Investigator# 52751
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Koga, Japan
- Site Reference ID/Investigator# 62025
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Matsumoto, Japan
- Site Reference ID/Investigator# 54384
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Midori, Japan
- Site Reference ID/Investigator# 52745
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Mito, Japan
- Site Reference ID/Investigator# 51569
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Nagano, Japan
- Site Reference ID/Investigator# 52964
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Nagano, Japan
- Site Reference ID/Investigator# 53483
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Nagasaki, Japan
- Site Reference ID/Investigator# 51582
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Nagoya, Japan
- Site Reference ID/Investigator# 54388
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Niigata, Japan
- Site Reference ID/Investigator# 51576
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Niigata, Japan
- Site Reference ID/Investigator# 51577
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Osaka, Japan
- Site Reference ID/Investigator# 51580
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Osaka, Japan
- Site Reference ID/Investigator# 52747
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Osaka, Japan
- Site Reference ID/Investigator# 52748
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Osaka, Japan
- Site Reference ID/Investigator# 52750
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Saitama, Japan
- Site Reference ID/Investigator# 51570
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Sakai, Japan
- Site Reference ID/Investigator# 54387
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Sapporo, Japan
- Site Reference ID/Investigator# 52746
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Shizuoka, Japan
- Site Reference ID/Investigator# 51579
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Takasaki, Japan
- Site Reference ID/Investigator# 62024
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Tokyo, Japan
- Site Reference ID/Investigator# 51572
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Tokyo, Japan
- Site Reference ID/Investigator# 52752
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Tokyo, Japan
- Site Reference ID/Investigator# 53482
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Tokyo, Japan
- Site Reference ID/Investigator# 59162
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Tokyo, Japan
- Site Reference ID/Investigator# 59966
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Tomakomai-shi, Japan
- Site Reference ID/Investigator# 53783
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Toyama, Japan
- Site Reference ID/Investigator# 54383
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Wakayama, Japan
- Site Reference ID/Investigator# 52749
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Yachiyoshi, Japan
- Site Reference ID/Investigator# 52962
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Yokohama-Shi, Japan
- Site Reference ID/Investigator# 59163
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Adult Chronic Kidney Disease (CKD) Stage 5 patients undergoing dialysis with stable dialysate calcium and phosphate binders
- On three times weekly hemodialysis for at least 3 months prior with intact parathyroid hormone (iPTH) greater than or equal to 300 pg/mL, adjusted normalized serum total calcium (Ca) greater than or equal to 8.4 to less than 10.2 mg/dL, serum phosphorus (P) less than or equal to 6.5 mg/dL.
Exclusion Criteria:
- Patients with a recent history of severe cardiovascular or hepatic disease, uncontrolled hypertension or uncontrolled diabetes
- Patients who have received a parathyroidectomy or ethanol infusion within the prior year
- Patients taking drugs that affect iPTH, calcium or bone metabolism
- Patients who will need to take chronic doses (greater than or equal to 2 consecutive weeks) of cytochrome P450 inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)
- Female patients who are pregnant, possibly pregnant, wish to become pregnant, or participate in breastfeeding during the study period.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Paricalcitol
Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks.
After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
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Andre navne:
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Aktiv komparator: Maxacalcitol
Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks.
After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
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Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia
Tidsramme: iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13).
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The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment, and with no hypercalcemia during the treatment phase.
Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL.
iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.
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iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13).
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia
Tidsramme: Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13).
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The percentage of participants with greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment and with no hypercalcemia during the treatment phase.
iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.
Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL.
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Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13).
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Percentage of Participants With Target Intact Parathyroid Hormone (iPTH)
Tidsramme: The last three weeks of treatment (Weeks 11, 12, and 13)
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The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment.
iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.
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The last three weeks of treatment (Weeks 11, 12, and 13)
|
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Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline
Tidsramme: Baseline to the last three weeks of treatment (Weeks 11, 12, and 13)
|
The percentage of participants with a greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment.
iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.
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Baseline to the last three weeks of treatment (Weeks 11, 12, and 13)
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Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline
Tidsramme: Weeks 2 to 13
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iPTH control was defined as a ≥ 50% reduction from baseline.
iPTH was measured before the first dialysis session of the week, each week during the treatment phase and analyzed by the central laboratory.
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Weeks 2 to 13
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Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL
Tidsramme: Weeks 2 to 13
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iPTH control was defined as being within the target range of 60 to 180 pg/mL.
iPTH was measured before the first dialysis session of the week, once a week during the treatment phase and analyzed by the central laboratory.
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Weeks 2 to 13
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Kazuya Kobayashi, BA, AbbVie GK.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2011
Primær færdiggørelse (Faktiske)
1. april 2012
Studieafslutning (Faktiske)
1. april 2012
Datoer for studieregistrering
Først indsendt
25. april 2011
Først indsendt, der opfyldte QC-kriterier
25. april 2011
Først opslået (Skøn)
26. april 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. juni 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. april 2013
Sidst verificeret
1. april 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer
- Urologiske sygdomme
- Sygdomme i det endokrine system
- Nyreinsufficiens
- Parathyreoidea sygdomme
- Neoplastiske processer
- Nyresygdomme
- Nyreinsufficiens, kronisk
- Hyperparathyroidisme
- Neoplasma Metastase
- Hyperparathyroidisme, sekundær
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Beskyttelsesagenter
- Dermatologiske midler
- Mikronæringsstoffer
- Membrantransportmodulatorer
- Vitaminer
- Knogletæthedsbevarende midler
- Calciumregulerende hormoner og midler
- Antikarcinogene midler
- Vasokonstriktormidler
- Calciumkanalagonister
- Ergocalciferoler
- Calcitriol
- Maxacalcitol
Andre undersøgelses-id-numre
- M11-517
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 .