- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00091975
Zemplar® Capsule in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects on Hemodialysis or Peritoneal Dialysis
17 januari 2011 uppdaterad av: Abbott
A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of Zemplar® Capsule in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects on Hemodialysis or Peritoneal Dialysis
The objective of this study is to determine the safety and efficacy of Zemplar® Capsule versus placebo, in decreasing elevated intact parathyroid hormone levels in chronic kidney disease stage 5 subjects with secondary hyperparathyroidism on hemodialysis or peritoneal dialysis, while using the revised dose titration scheme.
Studieöversikt
Studietyp
Interventionell
Inskrivning
78
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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California
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San Diego, California, Förenta staterna, 92120
- California Institute of Renal Research
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 60057
- Georgetown University Medical Center
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Florida
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Fort Meyers, Florida, Förenta staterna, 33908
- Associates in Nephrology
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Gainesville, Florida, Förenta staterna, 32610
- University of Florida
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Hudson, Florida, Förenta staterna, 34667
- Outcomes Research International, Inc.
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Illinois
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Evanston, Illinois, Förenta staterna, 60201
- Evanston Northwestern Healthcare
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46202
- Indiana University School of Medicine
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70112-2699
- Tulane University School of Medicine
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Missouri
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St. Louis, Missouri, Förenta staterna, 63110
- St. Louis University
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St. Louis, Missouri, Förenta staterna, 63108
- Washington University Medical Center
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89102
- Nea Research
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45267-0585
- University of Cincinnati College of Medicine
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Oregon
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Portland, Oregon, Förenta staterna, 97210
- Northwestern Renal Clinic, INC.
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37205
- Nephrology Associates, P.C.
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Texas
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Houston, Texas, Förenta staterna, 77030
- Kidney Associates, PLLC
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San Antonio, Texas, Förenta staterna, 78229
- University of Texas Health Center at San Antonio
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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
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria
- Subject was at least 18 years of age, diagnosed with CKD Stage 5 and undergoing HD or PD.
- If female, subject was either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or was of childbearing potential and practicing 1 of the protocol specified methods of birth control, was not breastfeeding and had a negative serum pregnancy test prior to the Treatment Phase.
- For those subjects taking phosphate binders prior to the study, the subject had to have been on a stable (type and dose) phosphate binder at least 4 weeks prior to the Pretreatment Phase.
- For entry into the Pretreatment Phase, the subject must have had a calcium level <= 10.5 mg/dL and a CaxP level <= 65 mg2/dL2.
- For entry into the Treatment Phase, the subject must have had iPTH >= 300 pg/mL (determined by Nichols iPTH assay), a calcium level of 8.0 to 10.5 mg/dL, inclusive, and CaxP <= 65 mg2/dL2.
- Subject voluntarily signed and dated an informed consent, approved by an Institutional Review Board (IRB), after the nature of the study was explained and the subject had the opportunity to ask questions. The informed consent was signed before any study-specific procedures were performed or any medications were withheld.
- Additional criteria for HD subjects included the following: the subject was diagnosed with CKD Stage 5 and must have been on maintenance HD 3 times a week (TIW) for at least 2 months prior to the Screening Phase and was expected to remain on HD for the duration of the study.
- Additional criteria for PD subjects, included the following: the subject was diagnosed with CKD Stage 5 and must have been on continuous PD (either continuous cycling peritoneal dialysis [CCPD], continuous ambulatory peritoneal dialysis [CAPD], or a combination of the 2) 7 days per week for at least 2 months prior to the Screening Phase and was expected to remain on this PD regimen for the duration of the study.
Exclusion Criteria
- Subject had a history of an allergic reaction or significant sensitivity to drugs similar to the study drug.
- Subject received a partial parathyroidectomy within 1 year prior to the Screening Phase.
- Subject had acute renal failure within 3 months of the Screening Phase.
- Subject had chronic gastrointestinal disease, which in the investigator's opinion, may have resulted in clinically significant gastrointestinal malabsorption.
- Subject had taken aluminum-containing phosphate binders for > 3 weeks in the last 3 months prior to the Screening Phase, or required such medications for > 3 weeks in the study.
- Subject had 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 had a history of drug or alcohol abuse within 6 months prior to the Screening Phase.
- Subject had evidence of poor compliance with diet, medication or HD/PD that may have interfered, in the investigator's opinion, with adherence to the protocol.
- Subject had participated in any investigational drug or device study within 4 weeks prior to the Treatment Phase.
- Subject was taking calcitonin, maintenance IV or oral glucocorticoids, cinacalcet, bisphosphonates, vitamin D compounds (other than study drug), or other drugs that may have affected calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy.
- Subject was known to be human immunodeficiency virus (HIV) positive.
- For any reason, subject was considered by the investigator to be an unsuitable candidate to receive Zemplar.
- Additional exclusion criteria for PD subjects, were: Subject had active peritonitis within 1 month prior to the Screening Phase; Subject had more than 1 episode of peritonitis within 4 months prior to the Screening Phase.
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: Parallellt uppdrag
- Maskning: Dubbel
Vad mäter studien?
Primära resultatmått
Resultatmått |
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The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline in iPTH levels
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Laura A Williams, M.D., MPH, Abbott
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
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 augusti 2004
Studieregistreringsdatum
Först inskickad
20 september 2004
Först inskickad som uppfyllde QC-kriterierna
21 september 2004
Första postat (Uppskatta)
22 september 2004
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
19 januari 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 januari 2011
Senast verifierad
1 juli 2006
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- M03-635
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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