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

NCT00257920 | Completed Phase 4 Results

• 1 other identifier: M04-726
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Kidney Disease, Stage 5; Secondary Hyperparathyroidism

Keywords

Stage 5 Chronic Kidney Disease (CKD)

Outcome Measures

Primary Outcomes (1)

• Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA)

  Calcium Absorption Fraction obtained at the end of Period 1 \& Period 2

  42 Days

Secondary Outcomes (1)

• Calcium Absorption Fractions Analyzed by Mixed Model

  42 Days

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: Zemplar® injection

B

ACTIVE COMPARATOR

Drug: Hectorol® injection

Interventions

Zemplar® injection DRUG

6 mcg QOD

Also known as: ABT-358, paricalcitol, Zemplar

A

Hectorol® injection DRUG

3.6 mcg QOD

Also known as: Hectorol®

B

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (2)

Unknown Facility

Bellevue, Nebraska, 68123, United States

Location

Unknown Facility

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperparathyroidism, Secondary

Interventions

paricalcitol; 1 alpha-hydroxyergocalciferol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Limitations and Caveats

The null hypothesis was not tested appropriately as a result of measurable differences in parathyroid hormone (PTH) suppression indicating dose exposure was different. Therefore, differences in calcium absorption could not be determined.

Results Point of Contact

• Title: Medical Information Specialist
• Organization: Abbott

1-800-633-9110

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 24, 2005
• Study Start: June 1, 2006
• Primary Completion: January 1, 2008
• Last Updated: December 24, 2009
• Results First Posted: May 20, 2009

Record last verified: 2009-12

Locations

US (2)