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


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


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


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

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

      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 
Muralidhar Acharya, M.D.,  Principal Investigator

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

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

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

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

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

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

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

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

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

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

      Kidney Associates, PLLC, Houston,  Texas,  77030,  United States; Recruiting
Cassie Brown, P.A.  713-795-5511 
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 
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 Identifier:  NCT00091975
Health Authority: United States: Food and Drug Administration processed this record on 2005-04-08

Cache Date: April 9, 2005