Zemplar® Capsule in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects on Hemodialysis or Peritoneal Dialysis
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ClinicalTrials.gov Identifier: NCT00091975 |
Recruitment Status :
Completed
First Posted : September 22, 2004
Last Update Posted : January 19, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Kidney Disease | Drug: Zemplar Capsule | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 78 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 |
Study Start Date : | August 2004 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00091975
United States, California | |
California Institute of Renal Research | |
San Diego, California, United States, 92120 | |
United States, District of Columbia | |
Georgetown University Medical Center | |
Washington, District of Columbia, United States, 60057 | |
United States, Florida | |
Associates in Nephrology | |
Fort Meyers, Florida, United States, 33908 | |
University of Florida | |
Gainesville, Florida, United States, 32610 | |
Outcomes Research International, Inc. | |
Hudson, Florida, United States, 34667 | |
United States, Illinois | |
Evanston Northwestern Healthcare | |
Evanston, Illinois, United States, 60201 | |
United States, Indiana | |
Indiana University School of Medicine | |
Indianapolis, Indiana, United States, 46202 | |
United States, Louisiana | |
Tulane University School of Medicine | |
New Orleans, Louisiana, United States, 70112-2699 | |
United States, Missouri | |
Washington University Medical Center | |
St. Louis, Missouri, United States, 63108 | |
St. Louis University | |
St. Louis, Missouri, United States, 63110 | |
United States, Nevada | |
Nea Research | |
Las Vegas, Nevada, United States, 89102 | |
United States, Ohio | |
University of Cincinnati College of Medicine | |
Cincinnati, Ohio, United States, 45267-0585 | |
United States, Oregon | |
Northwestern Renal Clinic, INC. | |
Portland, Oregon, United States, 97210 | |
United States, Tennessee | |
Nephrology Associates, P.C. | |
Nashville, Tennessee, United States, 37205 | |
United States, Texas | |
Kidney Associates, PLLC | |
Houston, Texas, United States, 77030 | |
University of Texas Health Center at San Antonio | |
San Antonio, Texas, United States, 78229 |
Study Director: | Laura A Williams, M.D., MPH | Abbott |
ClinicalTrials.gov Identifier: | NCT00091975 |
Other Study ID Numbers: |
M03-635 |
First Posted: | September 22, 2004 Key Record Dates |
Last Update Posted: | January 19, 2011 |
Last Verified: | July 2006 |
Chronic Kidney Disease |
Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |