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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.
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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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