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Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Daily Dosing)

31. juli 2006 opdateret af: Abbott

The objective of this study is to determine whether paricalcitol is safe and effective compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney disease.

Studieoversigt

Status

Afsluttet

Betingelser

Nyreinsufficiens, kronisk

Intervention / Behandling

Medicin: paricalcitol capsule

Undersøgelsestype

Interventionel

Tilmelding

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- California
  - Los Angeles, California, Forenede Stater, 90073
    - VA Greater Los Angeles Healthcare System, West Los Angeles
  - Riverside, California, Forenede Stater, 92501
    - Nephrology Associates Medical Group
  - Simi Valley, California, Forenede Stater, 93065
    - Kidney Center, Inc.
- Colorado
  - Denver, Colorado, Forenede Stater, 80220
    - Denver Nephrologists
  - Denver, Colorado, Forenede Stater, 80262
    - University of CO Health Sciences Center
- Iowa
  - Des Moines, Iowa, Forenede Stater, 50309
    - Dialysis PC
- Minnesota
  - Arden Hills, Minnesota, Forenede Stater, 55126
    - Twin Cities Clinical Research
- New York
  - Brooklyn, New York, Forenede Stater, 11201
    - Long Island College Hospital
  - Buffalo, New York, Forenede Stater, 14215
    - Erie County Medical Center
- Pennsylvania
  - Philadelphia, Pennsylvania, Forenede Stater, 19140
    - Temple University Hospital
- South Carolina
  - Charleston, South Carolina, Forenede Stater, 29425
    - Medical University of South Carolina
- South Dakota
  - Sioux Falls, South Dakota, Forenede Stater, 57105
    - Avera McKennan Research Institute
- Tennessee
  - Nashville, Tennessee, Forenede Stater, 37205
    - Nephrology Associates
- Texas
  - San Antonio, Texas, Forenede Stater, 78219
    - San Antonio Kidney Disease Research Center
- Virginia
  - Norfolk, Virginia, Forenede Stater, 23507
    - Clinical Research Associates of Tidewater
- Washington
  - Tacoma, Washington, Forenede Stater, 98405
    - FHS Research Center
Polen
- - Bialymstoku, Polen
    - Wojewodzki Szpital Specjalistyczny AM w Bialymstoku
  - Krakow, Polen
    - Krakow Hospital

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Under care of physician at least 2 months (for CKD)
Not on active Vitamin D therapy for at least 4 weeks prior
If female:
- Not of childbearing potential, OR,
- Practicing birth control
- Not breastfeeding
If taking phosphate binders, on a stable regimen at least 4 weeks prior
For entry into Pretreatment Phase:
- iPTH at least 120 pg/mL
- GFR of 15-60 mL/min and no dialysis expected for at least 6 months
For entry into Treatment Phase:
- Average of 2 consecutive iPTH values of at least 150 pg/mL, taken at least 1 day apart (all values not less than 120 pg/mL_
- 2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dL
- 2 consecutive serum phosphorus levels of not more than 5.2 mg/mL

Exclusion Criteria:

History of allergic reaction or sensitivity to similar drugs
Acute Renal Failure within 12 weeks of study
Chronic gastrointestinal disease
Spot urine result demonstrating a urine-calcium-to-urine creatinine ratio of greater than 0,2, or a history of renal stones
Taken aluminum-containing phosphate binders within last 12 weeks, or requires such medication for more than 3 weeks during study
Current malignancy, or clinically significant liver disease
Active granulomatous disease (TB, sarcoidosis, etc.)
History of drug or alcohol abuse within 6 months prior
Evidence of poor compliance with diet or medication
Received any investigational drug or participated in any device trial within 30 days prior
Taking maintenance calcitonin, bisphosphonates, or drugs that may affect calcium or bone metabolism (other than females on stable estrogen and/or progestin therapy)
On glucocorticoids for a period of more than 14 days within the last 6 months
HIV positive

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline in iPTH levels

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Abbott

Efterforskere

Studieleder: Laura Williams, M.D., Abbott

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. februar 2002

Datoer for studieregistrering

Først indsendt

1. november 2002

Først indsendt, der opfyldte QC-kriterier