Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Omaha, Nebraska 68131


Purpose:

A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects.


Criteria:

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.


Study is Available At:


Original ID:

M01-375


NCT ID:

NCT00073710


Secondary ID:


Study Acronym:


Brief Title:

Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium


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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

20 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Abbott


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:


Overall Contact Information

Official Name:Richard Lund, M.D.
Principal Investigator
Creighton University

Study Dates

Start Date:September 2004
Verification Date:July 2006
Last Changed Date:July 31, 2006
First Received Date:December 3, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure: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.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Zemplar
Intervention Type:Procedure
Name:42 Ca carbonate absorption via single tracer metho
Intervention Type:Drug
Name:Calcijex

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Abbott

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.