A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease

Secondary Hyperparathyroidism Clinical Trial

Official title:

A Phase 4, Single-Center, Open-Label, Randomized, Active-Controlled, Cross-over Pilot Study to Evaluate the Effects of Two Vitamin D Analogs, Zemplar® Injection and Hectorol® Injection, on Intestinal Absorption of Calcium in CKD Stage 5 Subjects on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257920
• Other study ID #: M04-726
• Status: Completed
• Phase: Phase 4
• First received: November 22, 2005
• Last updated: December 22, 2009
• Start date: June 2006

Study information

• Verified date: December 2009
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of Zemplar® Injection and Hectorol® Injection on intestinal calcium absorption in Chronic Kidney Disease Stage 5 subjects on hemodialysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. primary completion date: January 2008
• 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 CKD Stage 5, and must be on maintenance (chronic) hemodialysis (HD) three times a week for at least 2 months prior to the Screening Visit 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 has an intact PTH value > 200 pg/mL at Screening only (or Re-screening, if applicable).

• Subject has a serum calcium level < 10.2 mg/dL at Screening only (or Re-screening, if applicable).

• Subject has a serum phosphorus level < 6.5 mg/dL at Screening only (or Re-screening, if applicable).

• Subject has a CaxP product <= 65 at Screening only (or Re-screening, if applicable).

• Subject 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 (SGOT/AST, SGPT/ALT) levels.

• Subject has a hemoglobin level < 9.0 g/dL.

• Subject is taking maintenance calcitonin, Sensipar® (cinacalcet), glucocorticoids in an equivalent dose > 5 mg prednisone daily, or other drugs that may affect calcium or bone metabolism within 2 weeks prior to screening, 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease, Stage 5
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Intervention

Drug:
• Zemplar® injection
6 mcg QOD
• Hectorol® injection
3.6 mcg QOD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA)		42 Days	No
Secondary	Calcium Absorption Fractions Analyzed by Mixed Model		42 Days	No