Secondary HyperparathyroidismPhase 3NCT00042653
A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on Dialysis
A Phase 3 study testing AMG 073 in people with Secondary Hyperparathyroidism and End Stage Renal Disease, run by Amgen.
Trial summary
This 6 month 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism, End Stage Renal Disease
- 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
- 380 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Jul 2003
- Phase
- Phase 3
- 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
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.
About this study
Official title: A Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of Chronic Kidney Disease (Hemodialysis and Peritoneal Dialysis)
This 6 month 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.
- Being tested
- Placebo, AMG 073
- Medical subject headings
- Hyperparathyroidism, Secondary, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
30 mg of placebo taken once daily orally 60 mg of placebo taken once daily orally 90 mg of placebo taken once daily orally 120 mg of placebo taken once daily orally 180 mg of placebo taken once daily orally
AMG 073Drug
30 mg of AMG 073 taken once daily orally 60 mg of AMG 073 taken once daily orally 90 mg of AMG 073 taken once daily orally 120 mg of AMG 073 taken once daily orally 180 mg of AMG 073 taken once daily orally
| Study group | Role | What they receive |
|---|---|---|
| AMG 073 | Experimental | AMG 073 Receives: Drug: AMG 073 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Efficacy Assessment phase - final 10 weeks of study
Secondary outcomes (3)
To evaluate the efficacy of AMG 073 compared with placebo by determining: the proportion of subjects with a reduction from baseline in mean iPTH of >= 30% during the efficacy assessment phase
Measured: Efficacy Assessment phase - final 10 weeks of study
To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in iPTH during the efficacy assessment phase
Measured: Efficacy Assessment phase - final 10 weeks of study
To evaluate the safety of AMG 073 compared with placebo
Measured: Entire study - 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2002 (estimated)
- Study startMay 2002
- Primary completionJul 2003
- Study completionJul 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 Secondary HyperparathyroidismStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 380 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
- NCT00042653
- Sponsor's protocol ID
- 20000188
- Status last verified
- May 2013
- First submitted
- 2 Aug 2002
- Last updated
- 8 May 2013
- Results posted
- No
Publications
Lindberg JS, Culleton B, Wong G, Borah MF, Clark RV, Shapiro WB, Roger SD, Husserl FE, Klassen PS, Guo MD, Albizem MB, Coburn JW. Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study. J Am Soc Nephrol. 2005 Mar;16(3):800-7. doi: 10.1681/ASN.2004060512. Epub 2005 Feb 2.
PubMed 15689407
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 Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of Chronic Kidney Disease (Hemodialysis and Peritoneal Dialysis)
- ClinicalTrials.gov ID
- NCT00042653
- Acronym / sponsor ID
- 20000188
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Jul 2003 (actual)
- Study completion
- Jul 2003 (actual)
- First posted
- 6 Aug 2002 (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.
This 6 month 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 073 | Experimental | Drug: AMG 073AMG 073 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Placebo30 mg of placebo taken once daily orally 60 mg of placebo taken once daily orally 90 mg of placebo taken once daily orally 120 mg of placebo taken once daily orally 180 mg of placebo taken once daily orally | Drug | Placebo |
| AMG 07330 mg of AMG 073 taken once daily orally 60 mg of AMG 073 taken once daily orally 90 mg of AMG 073 taken once daily orally 120 mg of AMG 073 taken once daily orally 180 mg of AMG 073 taken once daily orally | Drug | AMG 073 |
Primary outcome
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 - final 10 weeks of study
3 secondary outcomes
To evaluate the efficacy of AMG 073 compared with placebo by determining: the proportion of subjects with a reduction from baseline in mean iPTH of >= 30% during the efficacy assessment phase
Time frame: Efficacy Assessment phase - final 10 weeks of study
To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in iPTH during the efficacy assessment phase
Time frame: Efficacy Assessment phase - final 10 weeks of study
To evaluate the safety of AMG 073 compared with placebo
Time frame: Entire study - 26 weeks
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 15689407Lindberg JS, Culleton B, Wong G, Borah MF, Clark RV, Shapiro WB, Roger SD, Husserl FE, Klassen PS, Guo MD, Albizem MB, Coburn JW. Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study. J Am Soc Nephrol. 2005 Mar;16(3):800-7. doi: 10.1681/ASN.2004060512. Epub 2005 Feb 2.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- FDA-approved Drug LabelingLink provided by the sponsor.
Related trials for Secondary Hyperparathyroidism
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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 3 study testing AMG 073 in people with Secondary Hyperparathyroidism and End Stage Renal Disease, 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?
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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 - final 10 weeks of 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 NCT00042653, 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.