Clinical Trial: Zemplar® Capsule in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects on Hemodialysis or Peritoneal Dialysis

This study is currently recruiting patients.

Sponsored by: Abbott Laboratories
Information provided by: Abbott Laboratories

Purpose

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.

Condition Treatment or Intervention Phase
Kidney Disease
 Drug: Zemplar Capsule
Phase III

MedlinePlus related topics:  Kidney Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control

Official Title: 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

Further Study Details: 

Study start: August 2004

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Subjects with Chronic Kidney Disease Stage 5 with secondary hyperparathyroidism who are on hemodialysis three times a week or on continuous peritoneal dialysis 7 days a week at least 2 months prior to screening will be eligible for treatment with Zemplar® Capsule.

Location and Contact Information

Michelle Bagdon, Bachelors of Science      (847) 935-1929    michelle.bagdon@abbott.com

California
      California Institute of Renal Research, San Diego,  California,  92120,  United States; Recruiting
Sami Hania  619-287-0688    cirrsamihania@peoplepc.com 
George Z. Fadda, M.D.,  Principal Investigator

Florida
      Associates in Nephrology, Fort Meyers,  Florida,  33908,  United States; Recruiting
Michelle Mahaney  239-425-6631 
K. Deva Caanthan, M.D.,  Principal Investigator

      Outcomes Research International, Inc., Hudson,  Florida,  34667,  United States; Recruiting
Heather Gunes  727-863-4069    hgunes@rapidsys.com 
Muralidhar Acharya, M.D.,  Principal Investigator

      University of Florida, Gainesville,  Florida,  32610,  United States; Recruiting
Tracy Hollen  352-265-6890    holletl@medicine.ufl.edu 
Edward A Ross, M.D.,  Principal Investigator

Illinois
      Evanston Northwestern Healthcare, Evanston,  Illinois,  60201,  United States; Recruiting
Pam Schinleber  847-570-1761    pschinleber@enh.org 
Stuart Sprague, DO,  Principal Investigator

Indiana
      Indiana University School of Medicine, Indianapolis,  Indiana,  46202,  United States; Completed

Louisiana
      Tulane University School of Medicine, New Orleans,  Louisiana,  70112-2699,  United States; Recruiting
Brian Mahl  504.988.2026    bmahl@tulane.edu 
L. Lee Hamm, III, M.D.,  Principal Investigator

Missouri
      Washington University Medical Center, St. Louis,  Missouri,  63108,  United States; Recruiting
Sue Dombek  314-286-0819    sdombek@im.wustl.edu 
Daniel W Coyne, M.D.,  Principal Investigator

      St. Louis University, St. Louis,  Missouri,  63110,  United States; Recruiting
Michelle Brynd  314-577-8765    bryndaml@slu.edu 
Esther Gonzalez, MD,  Principal Investigator

Nevada
      Nea Research, Las Vegas,  Nevada,  89102,  United States; Recruiting
Helen Krouse  702-877-1246    hlkrouse@lvcm.com 
Marc . Leiserowitz, ,M.D,  Principal Investigator

Ohio
      University of Cincinnati College of Medicine, Cincinnati,  Ohio,  45267-0585,  United States; Recruiting
Heather Duncan  513-281-0091    heather.duncan@uc.edu 
Shashi Kant, MD,  Principal Investigator

Oregon
      Northwestern Renal Clinic, INC., Portland,  Oregon,  97210,  United States; Recruiting
Brent Echols  503-229-7976    bsechols@nwrc.com 
Michael Walczyk, M.D.,  Principal Investigator

Tennessee
      Nephrology Associates, P.C., Nashville,  Tennessee,  37205,  United States; Recruiting
Sallyanne Meier  615-354-2447    sallyannemeier@hotmail.com 
Mark Kaplan, M.D.,  Principal Investigator

Texas
      Kidney Associates, PLLC, Houston,  Texas,  77030,  United States; Recruiting
Cassie Brown, P.A.  713-795-5511    cbrown@tmh.tmc.edu 
Stephen Z. Fadem, M.D.,  Principal Investigator

      University of Texas Health Center at San Antonio, San Antonio,  Texas,  78229,  United States; Recruiting
Cary Goyes  210-567-0015    GOYES@uthscsa.edu 
Hanna Abboud, M.D.,  Principal Investigator

More Information

Study ID Numbers:  M03-635
Record last reviewed:  March 2005
Last Updated:  March 16, 2005
Record first received:  September 20, 2004
ClinicalTrials.gov Identifier:  NCT00091975
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources