Secondary HyperparathyroidismPhase 2NCT00042432
Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
A Phase 2 study testing cinacalcet (AMG 073) in people with Secondary Hyperparathyroidism and Chronic Renal Insufficiency, run by Amgen.
Trial summary
This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism, Chronic Renal Insufficiency
- What is being tested?
- cinacalcet (AMG 073)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Aug 2003
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must have chronic renal insufficiency (pre-dialysis)
- Have below normal creatinine clearance
- Have elevated parathyroid hormone levels
Who cannot join
- Pregnant or nursing
- Heart attack in the last 3 months.
About this study
Official title: A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.
- Being tested
- cinacalcet (AMG 073)
- Medical subject headings
- Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cinacalcet (AMG 073)Drug
Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| cinacalcet (AMG 073) | Experimental | Not described Receives: Drug: cinacalcet (AMG 073) |
| Placebo | Placebo comparator | Not described Receives: Drug: cinacalcet (AMG 073) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase
Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase
Measured: Efficacy assessment phase (weeks 12-18)
Secondary outcomes (1)
Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase
Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase
Measured: Baseline, efficacy assessment phase (weeks 12-18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2002 (estimated)
- Study startJun 2002
- Primary completionMar 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042432
- Sponsor's protocol ID
- 20010239
- Status last verified
- May 2013
- First submitted
- 29 Jul 2002
- Last updated
- 13 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Charytan C, Coburn JW, Chonchol M, Herman J, Lien YH, Liu W, Klassen PS, McCary LC, Pichette V. Cinacalcet hydrochloride is an effective treatment for secondary hyperparathyroidism in patients with CKD not receiving dialysis. Am J Kidney Dis. 2005 Jul;46(1):58-67. doi: 10.1053/j.ajkd.2005.04.013.
PubMed 15983958
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
- ClinicalTrials.gov ID
- NCT00042432
- Acronym / sponsor ID
- 20010239
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Mar 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 1 Aug 2002 (estimated)
- Results
- Posted 1 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.
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 |
|---|---|---|
| cinacalcet (AMG 073) | Experimental | Drug: cinacalcet (AMG 073) |
| Placebo | Placebo comparator | Drug: cinacalcet (AMG 073) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have chronic renal insufficiency (pre-dialysis)
- Have below normal creatinine clearance
- Have elevated parathyroid hormone levels
Key exclusion criteria (2 listed)
- Pregnant or nursing
- Heart attack in the last 3 months.
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 |
|---|---|---|
| cinacalcet (AMG 073)Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks. | Drug | Placebo, cinacalcet (AMG 073) |
Primary outcome
Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase
Time frame: Efficacy assessment phase (weeks 12-18)
Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase
1 secondary outcome
Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase
Time frame: Baseline, efficacy assessment phase (weeks 12-18)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 15983958Charytan C, Coburn JW, Chonchol M, Herman J, Lien YH, Liu W, Klassen PS, McCary LC, Pichette V. Cinacalcet hydrochloride is an effective treatment for secondary hyperparathyroidism in patients with CKD not receiving dialysis. Am J Kidney Dis. 2005 Jul;46(1):58-67. doi: 10.1053/j.ajkd.2005.04.013.
- 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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A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
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Strategies for Proactive Health in People With Kidney Function Decline
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Osteoporosis & Renal Disease: Research in Primary Health Care Services
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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 cinacalcet (AMG 073) in people with Secondary Hyperparathyroidism and Chronic Renal Insufficiency, 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 3 inclusion and 2 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 13 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?
Yes. Results are posted in the registry (first posted 1 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase (time frame: Efficacy assessment phase (weeks 12-18)). 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 NCT00042432, 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 13 May 2013.