---
title: A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients
nct_id: NCT00037635
overall_status: COMPLETED
phase: PHASE3
sponsor: Amgen
study_type: INTERVENTIONAL
primary_condition: Secondary Hyperparathyroidism
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00037635.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00037635"
ct_last_update_post_date: 2013-05-08
last_seen_at: "2026-05-12T07:34:40.995Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients

**Official Title:** A Phase 3 Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of End Stage Renal Disease Treated With Hemodialysis

**NCT ID:** [NCT00037635](https://clinicaltrials.gov/study/NCT00037635)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 400
- **Lead Sponsor:** Amgen
- **Conditions:** Secondary Hyperparathyroidism, End Stage Renal Disease
- **Start Date:** 2001-12
- **Completion Date:** 2003-03
- **CT.gov Last Update:** 2013-05-08

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
* 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.
```

## Arms

- **AMG 073** (EXPERIMENTAL)
- **placebo** (PLACEBO_COMPARATOR)

## Interventions

- **AMG 073** (DRUG) — 30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
- **Placebo** (DRUG) — 30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally

## Primary Outcomes

- **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.** _(time frame: efficacy assessment phase (last 14 weeks of treatment))_

## Secondary Outcomes

- **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** _(time frame: 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** _(time frame: efficacy assessment phase (last 14 weeks of treatment))_
- **To evaluate the safety of AMG 073 compared with placebo.** _(time frame: entire study)_

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00037635.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00037635*  
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