Chronic Kidney Disease Clinical Trial
Official title:
A Phase IV, Single-Center, Active-Controlled Cross-Over Pilot Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
NCT number | NCT00073710 |
Other study ID # | M01-375 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | December 3, 2003 |
Last updated | July 31, 2006 |
Start date | September 2004 |
Verified date | July 2006 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects.
Status | Completed |
Enrollment | 30 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria - Subject is = 20 years of age. - Subject is diagnosed with ESRD, and must be on maintenance hemodialysis (HD) three times a week for at least 2 months prior to the Screening Phase and expected to remain on HD for the duration of the study. - If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: - Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) - Contraceptives (oral or parenteral) for three months prior to study drug administration - In a monogamous relationship with a vasectomized partner - If female, subject is not breastfeeding and has a negative serum pregnancy test prior to the treatment phase. - Subject had an intact PTH value > 200 pg/mL. - Serum calcium level < 10.2 mg/dL at Screening visit. - Serum phosphorus level < 6.5 mg/dL at Screening visit. - Ca´P product = 65 at Screening visit. - Must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the conduct of any study-specific procedure Exclusion Criteria - Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds. - Subject has chronic gastrointestinal disease, which in the Investigator's opinion, may result in clinically significant GI malabsorption. - Liver function defects defined as > 2 times the upper limit of normal for liver enzyme or > 1.5 times the upper limit of normal coagulation levels. - Subject is taking maintenance calcitonin, glucocorticoids in an equivalent dose > 5 mg prednisone, or other drugs that may affect calcium or bone metabolism, other than females on stable (same dose and product for 3 months) estrogen and/or progestin therapy. - For any reason, subject is considered by the Investigator to be an unsuitable candidate to receive pharmacological doses of vitamin D. - Subject has received any investigational drug within 4 weeks prior to the Treatment Phase. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Creighton University | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
Abbott |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The mean within subject difference in calcium absorption rates between treatment regimens will be analyzed using ANOVA appropriate for a two-period cross-over trial. |
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