Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease
20 december 2011 uppdaterad av: Abbott
A Phase 3b, Randomized, Active-Controlled, Single-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Injection in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects Receiving Hemodialysis
Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease
Studieöversikt
Detaljerad beskrivning
Evaluate the safety and efficacy of paricalcitol injection with two different dosing regimens (currently approved dosing regimen used in the US package insert versus dosing based on a formula of iPTH/80 that was approved and used in the EU package insert) in Chronic Kidney Disease (CKD) Stage 5 subjects with secondary hyperparathyroidism receiving hemodialysis.
Studietyp
Interventionell
Inskrivning (Faktisk)
216
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Beijing, Kina, 100034
- Site Reference ID/Investigator# 23483
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Beijing, Kina, 100044
- Site Reference ID/Investigator# 23485
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Beijing, Kina, 100730
- Site Reference ID/Investigator# 23482
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Dalian City, Kina, 116011
- Site Reference ID/Investigator# 23484
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Guangzhou City, Kina, 510080
- Site Reference ID/Investigator# 23486
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Nanjing, Kina, 210029
- Site Reference ID/Investigator# 23488
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Qingdao, Kina, 266003
- Site Reference ID/Investigator# 37722
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Shanghai, Kina, 200001
- Site Reference ID/Investigator# 23490
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Shanghai, Kina, 200001
- Site Reference ID/Investigator# 25502
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Shanghai, Kina, 200025
- Site Reference ID/Investigator# 23489
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Shanghai, Kina, 200092
- Site Reference ID/Investigator# 23487
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Wenzhou, Kina, 325000
- Site Reference ID/Investigator# 35822
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Subject is a Chinese male or female greater than or equal to 20 years old.
- Subject is diagnosed with Chronic Kidney Disease Stage 5 and must be on maintenance hemodialysis three times a week for at least 2 months prior to the Screening Visit and expected to remain on hemodialysis for the duration of the study.
For entry into the Treatment Phase, the subject must have:
- Intact parathyroid hormone greater than or equal to 300 pg/mL
- Serum calcium less than 10.2 mg/dL (2.55 mmol/L)
- Calcium-phosphorus product less than 65 mg^2/dL^2
Exclusion Criteria:
- Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
- Subject received a partial parathyroidectomy within one year prior to the Screening Phase.
- Subject with New York Heart Association (NYHA) Class III or IV.
- Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the Screening Phase, or requires such medications for greater than 3 weeks in the study.
- Subject has a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the Investigator.
- Subject has a history of drug or alcohol abuse within 6 months prior to the Screening Phase.
- Subject is known to be human immunodeficiency virus (HIV) positive.
- Subject has evidence of poor compliance with diet, medication or hemodialysis that may interfere, in the Investigator's opinion, with adherence to the protocol.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Group 1
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
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Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value.
See Arm Description for additional details.
Andra namn:
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Aktiv komparator: Group 2
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
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Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value.
See Arm Description for additional details.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels
Tidsram: Baseline to 12 Weeks
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The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values
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Baseline to 12 Weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL
Tidsram: Baseline to 12 Weeks
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The number of subjects with (Yes) or without (No) final intact parathyroid hormone (iPTH) values between 150 and 300 pg/mL
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Baseline to 12 Weeks
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The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value
Tidsram: Baseline to 12 Weeks
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Baseline to 12 Weeks
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The Change From Baseline to the Final Observation in Calcium
Tidsram: Baseline to 12 Weeks
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Baseline to 12 Weeks
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The Change From Baseline to the Final Observation in Calcium-phosphorus Product
Tidsram: Baseline to 12 Weeks
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Baseline to 12 Weeks
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The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure
Tidsram: Baseline to 12 Weeks
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Baseline to 12 Weeks
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The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure
Tidsram: Baseline to 12 Weeks
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Baseline to 12 Weeks
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The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate
Tidsram: Baseline to 12 Weeks
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Baseline to 12 Weeks
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The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)
Tidsram: Baseline to 12 weeks
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The number of subjects with (Yes) or without (No) two consecutive calcium measurements greater than 11.0 mg/dL (2.75 mmol/L)
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Baseline to 12 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Yue Kang, MD, Abbott (China)
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2009
Primärt slutförande (Faktisk)
1 november 2010
Avslutad studie (Faktisk)
1 november 2010
Studieregistreringsdatum
Först inskickad
25 november 2009
Först inskickad som uppfyllde QC-kriterierna
17 februari 2010
Första postat (Uppskatta)
19 februari 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
26 januari 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 december 2011
Senast verifierad
1 december 2011
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- M06-823
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