A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients

NCT00037635 | Completed Phase 3

• 1 other identifier: 20000172
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

This 6 month long study will assess an investigational medication for patients on dialysis with secondary hyperparathyroidism. The study will look at the effects on parathyroid hormone, calcium and phosphorus levels.

Conditions

Secondary Hyperparathyroidism; End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase.

  efficacy assessment phase (last 14 weeks of treatment)

Secondary Outcomes (3)

• To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in mean calcium x phosphorus product (Ca x P) during the efficacy assessment phase

  efficacy assessment phase (last 14 weeks of treatment)

• To evaluate the efficacy of AMG 073 compared with placebo by determining: changes in self-reported cognitive function from baseline to the end of the efficacy assessment phase

  efficacy assessment phase (last 14 weeks of treatment)

• To evaluate the safety of AMG 073 compared with placebo.

  entire study

Study Arms (2)

AMG 073

EXPERIMENTAL

Drug: AMG 073

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AMG 073 DRUG

30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally

AMG 073

Placebo DRUG

30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally

placebo

Eligibility Criteria

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

* Patients must be receiving hemodialysis; \* Have elevated parathyroid hormone levels; \* Not be pregnant or nursing; and \* Not have had a heart attack in the last 3 months.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Martin KJ, Juppner H, Sherrard DJ, Goodman WG, Kaplan MR, Nassar G, Campbell P, Curzi M, Charytan C, McCary LC, Guo MD, Turner SA, Bushinsky DA. First- and second-generation immunometric PTH assays during treatment of hyperparathyroidism with cinacalcet HCl. Kidney Int. 2005 Sep;68(3):1236-43. doi: 10.1111/j.1523-1755.2005.00517.x.

  PMID: 16105056 RESULT

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Kidney Failure, Chronic

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Renal Insufficiency, Chronic; 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

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 17, 2002
• First Posted: May 20, 2002
• Study Start: December 1, 2001
• Primary Completion: March 1, 2003
• Study Completion: March 1, 2003
• Last Updated: May 8, 2013

Record last verified: 2013-05