Renal OsteodystrophyPhase 2NCT00527085
12-month Study of AMG 073 in Renal Osteodystrophy
A Phase 2 study testing AMG 073 in people with Renal Osteodystrophy, run by Amgen.
Trial summary
4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In addition, a bone biopsy will be performed at screening and at the end of study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Osteodystrophy
- What is being tested?
- AMG 073
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Oct 2001to Aug 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age of greater
- Using effective contraceptive measures
- iPTH greater than or equal to 300 pg/mL
- Serum Calcium greater than or equal to 8.4 mg/dL; Hemoglobin greater than 9
- Stable hemodialysis for 1 month prior to day 1
Who cannot join
- Any unstable medical condition
- Pregnant or nursing women Recent parathyroidectomy
- Change in Vitamin D therapy
- Recent MI, Seizure, Malignancy, GI Disorder
- Inability to swallow tablets
About this study
Official title: A Multicenter, Randomized, Placebo-controlled, Double-blind, 12-month Study to Assess the Effects of an Oral Calcimimetic Agent (AMG 073) on Renal Osteodystrophy in Hemodialysis Patients With Secondary Hyperparathyroidism
4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In addition, a bone biopsy will be performed at screening and at the end of study.
- Conditions
- Renal Osteodystrophy
- Being tested
- AMG 073, Placebo
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 073Drug
30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
PlaceboDrug
30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
| Study group | Role | What they receive |
|---|---|---|
| AMG 073 | Experimental | Not described Receives: Drug: AMG 073 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry
Measured: entire study
Secondary outcomes (3)
To evaluate the effects of AMG 073 compared with placebo on intact parathyroid hormone (iPTH), bone-specific alkaline phosphatase (BALP), serum N-Telopeptide (N-Tx), and calcium x phosphorus product concentrations
Measured: entire study
To evaluate the feasibility of measuring physical activity with accelerometry
Measured: entire study
To evaluate the safety and tolerability of AMG 073 compared with placebo
Measured: entire study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startOct 2001
- Primary completionAug 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal OsteodystrophyStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527085
- Sponsor's protocol ID
- 20010141
- Status last verified
- May 2013
- First submitted
- 6 Sep 2007
- Last updated
- 8 May 2013
- Results posted
- No
Publications
Malluche HH, Monier-Faugere MC, Wang G, Fraza O JM, Charytan C, Coburn JW, Coyne DW, Kaplan MR, Baker N, McCary LC, Turner SA, Goodman WG. An assessment of cinacalcet HCl effects on bone histology in dialysis patients with secondary hyperparathyroidism. Clin Nephrol. 2008 Apr;69(4):269-78. doi: 10.5414/cnp69269.
PubMed 18397701
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-controlled, Double-blind, 12-month Study to Assess the Effects of an Oral Calcimimetic Agent (AMG 073) on Renal Osteodystrophy in Hemodialysis Patients With Secondary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT00527085
- Acronym / sponsor ID
- 20010141
- Conditions
- Renal Osteodystrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In addition, a bone biopsy will be performed at screening and at the end of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 073 | Experimental | Drug: AMG 073 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age of greater
- Using effective contraceptive measures
- iPTH greater than or equal to 300 pg/mL
- Serum Calcium greater than or equal to 8.4 mg/dL; Hemoglobin greater than 9
- Stable hemodialysis for 1 month prior to day 1
Key exclusion criteria (5 listed)
- Any unstable medical condition
- Pregnant or nursing women Recent parathyroidectomy
- Change in Vitamin D therapy
- Recent MI, Seizure, Malignancy, GI Disorder
- Inability to swallow tablets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 07330 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally | Drug | AMG 073 |
| Placebo30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally | Drug | Placebo |
Primary outcome
To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry
Time frame: entire study
3 secondary outcomes
To evaluate the effects of AMG 073 compared with placebo on intact parathyroid hormone (iPTH), bone-specific alkaline phosphatase (BALP), serum N-Telopeptide (N-Tx), and calcium x phosphorus product concentrations
Time frame: entire study
To evaluate the feasibility of measuring physical activity with accelerometry
Time frame: entire study
To evaluate the safety and tolerability of AMG 073 compared with placebo
Time frame: entire study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
- Results publication: PubMed 18397701Malluche HH, Monier-Faugere MC, Wang G, Fraza O JM, Charytan C, Coburn JW, Coyne DW, Kaplan MR, Baker N, McCary LC, Turner SA, Goodman WG. An assessment of cinacalcet HCl effects on bone histology in dialysis patients with secondary hyperparathyroidism. Clin Nephrol. 2008 Apr;69(4):269-78. doi: 10.5414/cnp69269.
- FDA-approved Drug LabelingLink provided by the sponsor.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMG 073 in people with Renal Osteodystrophy, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry (time frame: entire study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00527085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2013.