Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
This study has been completed.
Information provided by:
First received: December 3, 2003
Last updated: July 31, 2006
Last verified: July 2006
A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects.
Chronic Kidney Disease
Procedure: 42 Ca carbonate absorption via single tracer method
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- 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.
| Estimated Enrollment:
| Study Start Date:
|Ages Eligible for Study:
||20 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00073710
|Omaha, Nebraska, United States, 68131 |
||Richard Lund, M.D.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 3, 2003
||July 31, 2006
||United States: Food and Drug Administration
Keywords provided by Abbott:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 19, 2013
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Endocrine System Diseases
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action