End Stage Renal DiseasePhase 4NCT00110890
A Research Study for Patients With End-Stage Renal Disease (ESRD)
A Phase 4 study testing cinacalcet in people with End Stage Renal Disease, run by Amgen.
Trial summary
The purpose of this study is to evaluate the ability of a treatment strategy, that includes cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid hormone (PTH) compared with the standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- cinacalcet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Sep 2007
- Phase
- Phase 4
- 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
- ESRD patients requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month
- The mean of 2 iPTH determinations within 21 days before randomization and drawn at least 2 days apart must be greater than or equal to 300 pg/mL (31.8 pmol/L) and less than 800 pg/mL (84.8 pmol/L). If biPTH is determined, the mean levels must be greater than or equal to 150 pg/mL (15.9 pmol/L) and less than 410 pg/mL (43.5 pmol/L)
- The mean of 2 serum calcium determinations (corrected for albumin) drawn on the same day as the PTH determinations must be greater than or equal to 8.4 mg/dL (2.1 mmol/L)
Who cannot join
- Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator
- Have had a parathyroidectomy in the 6 months before day 1
- Have received vitamin D therapy for less than 21 days before day 1 or required a change in prescribed vitamin D brand or dose within 21 days before day 1. If subjects are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for the 21 days before day 1.
- Received, within 21 days before day 1 of the dose titration phase, therapy with medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic index (e.g., flecainide, vinblastine, thioridazine, and most tricyclic antidepressants). The tricyclic antidepressant amitriptyline is permitted. - Experienced a myocardial infarction within 3 months prior to day 1
- Are currently enrolled in, or have not yet completed at least 30 days before day 1, other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable)
- Have a gastrointestinal disorder that may be associated with impaired absorption or orally administered medications or an inability to swallow tablets
About this study
Official title: An Open-Label, Randomised Study Using Cinacalcet to Improve Achievement of Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With ESRD
The purpose of this study is to evaluate the ability of a treatment strategy, that includes cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid hormone (PTH) compared with the standard of care.
- Conditions
- End Stage Renal Disease
- Being tested
- cinacalcet, Standard of care
- Keywords
- Secondary HyperParaThyroidism (SHPT), Dialysis, End Stage Renal Disease (ESRD), KDOQI, Cinacalcet, Clinical Trial, Amgen
- Medical subject headings
- Kidney Failure, Chronic, Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cinacalcetDrug
Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg.
Standard of careOther
Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets. Receives: Other: Standard of care |
| Cinacalcet | Other | Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on iPTH values. Receives: Drug: cinacalcet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Mean PTH ≤ 300 pg/mL
Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase
Measured: Efficacy Assessment Phase (weeks 17 to 23)
Secondary outcomes (4)
Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL
Number of participants with mean calcium x phosphorus (Ca x P) < 55 mg^2/dL^2 and intact parathyroid hormone (iPTH) ≤ 300 pg/mL during the efficacy assessment phase
Measured: Efficacy Assesment Phase (weeks 17-23)
Number of Participants With Mean Ca x P < 55 mg^2/dL^2
Number of participants with mean calcium x phosphorus (Ca x P) < 55 mg^2/dL^2 during the efficacy assessment phase
Measured: Efficacy Assessment Phase (weeks 17 to 23)
Number of Participants With Mean Serum Ca < 9.5 mg/dL
Number of participants with mean serum calcium (Ca) < 9.5 mg/dL during the efficacy assessment phase
Measured: Efficacy Assessment Phase (weeks 17-23)
Number of Participants With Mean Serum P < 5.5 mg/dL
Number of participants with mean serum phosphorus (P) < 5.5 mg/dL during the efficacy assessment phase
Measured: Efficacy Assessment Phase (weeks 17 to 23)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2005 (estimated)
- Study startMay 2004
- Primary completionApr 2005
- Study completionSep 2007
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 (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 552 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
- NCT00110890
- Sponsor's protocol ID
- 20030187
- Status last verified
- Feb 2011
- First submitted
- 16 May 2005
- Last updated
- 7 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Messa P, Macario F, Yaqoob M, Bouman K, Braun J, von Albertini B, Brink H, Maduell F, Graf H, Frazao JM, Bos WJ, Torregrosa V, Saha H, Reichel H, Wilkie M, Zani VJ, Molemans B, Carter D, Locatelli F. The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism. Clin J Am Soc Nephrol. 2008 Jan;3(1):36-45. doi: 10.2215/CJN.03591006.
PubMed 18178780Wilkie M, Pontoriero G, Macario F, Yaqoob M, Bouman K, Braun J, von Albertini B, Brink H, Maduell F, Graf H, Frazao JM, Bos WJ, Torregrosa V, Saha H, Reichel H, Zani VJ, Carter D, Messa P. Impact of vitamin D dose on biochemical parameters in patients with secondary hyperparathyroidism receiving cinacalcet. Nephron Clin Pract. 2009;112(1):c41-50. doi: 10.1159/000212102. Epub 2009 Apr 10.
PubMed 19365139Frazao JM, Braun J, Messa P, Dehmel B, Mattin C, Wilkie M. Is serum phosphorus control related to parathyroid hormone control in dialysis patients with secondary hyperparathyroidism? BMC Nephrol. 2012 Aug 3;13:76. doi: 10.1186/1471-2369-13-76.
PubMed 22863242
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomised Study Using Cinacalcet to Improve Achievement of Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With ESRD
- ClinicalTrials.gov ID
- NCT00110890
- Acronym / sponsor ID
- 20030187
- Conditions
- End Stage Renal Disease
- Keywords
- Secondary HyperParaThyroidism (SHPT), Dialysis, End Stage Renal Disease (ESRD), KDOQI, Cinacalcet, Clinical Trial, Amgen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 17 May 2005 (estimated)
- Results
- Posted 7 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the ability of a treatment strategy, that includes cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid hormone (PTH) compared with the standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | Other: Standard of careSubjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets. |
| Cinacalcet | Other | Drug: cinacalcetTreatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on iPTH values. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ESRD patients requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month
- The mean of 2 iPTH determinations within 21 days before randomization and drawn at least 2 days apart must be greater than or equal to 300 pg/mL (31.8 pmol/L) and less than 800 pg/mL (84.8 pmol/L). If biPTH is determined, the mean levels must be greater than or equal to 150 pg/mL (15.9 pmol/L) and less than 410 pg/mL (43.5 pmol/L)
- The mean of 2 serum calcium determinations (corrected for albumin) drawn on the same day as the PTH determinations must be greater than or equal to 8.4 mg/dL (2.1 mmol/L)
Key exclusion criteria (6 listed)
- Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator
- Have had a parathyroidectomy in the 6 months before day 1
- Have received vitamin D therapy for less than 21 days before day 1 or required a change in prescribed vitamin D brand or dose within 21 days before day 1. If subjects are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for the 21 days before day 1.
- Received, within 21 days before day 1 of the dose titration phase, therapy with medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic index (e.g., flecainide, vinblastine, thioridazine, and most tricyclic antidepressants). The tricyclic antidepressant amitriptyline is permitted. - Experienced a myocardial infarction within 3 months prior to day 1
- Are currently enrolled in, or have not yet completed at least 30 days before day 1, other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable)
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 |
|---|---|---|
| cinacalcetTreatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. | Drug | Cinacalcet |
| Standard of careSubjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets. | Other | Standard of care |
Primary outcome
Number of Participants With Mean PTH ≤ 300 pg/mL
Time frame: Efficacy Assessment Phase (weeks 17 to 23)
Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase
4 secondary outcomes
Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL
Time frame: Efficacy Assesment Phase (weeks 17-23)
Number of Participants With Mean Ca x P < 55 mg^2/dL^2
Time frame: Efficacy Assessment Phase (weeks 17 to 23)
Number of Participants With Mean Serum Ca < 9.5 mg/dL
Time frame: Efficacy Assessment Phase (weeks 17-23)
Number of Participants With Mean Serum P < 5.5 mg/dL
Time frame: Efficacy Assessment Phase (weeks 17 to 23)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18178780Messa P, Macario F, Yaqoob M, Bouman K, Braun J, von Albertini B, Brink H, Maduell F, Graf H, Frazao JM, Bos WJ, Torregrosa V, Saha H, Reichel H, Wilkie M, Zani VJ, Molemans B, Carter D, Locatelli F. The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism. Clin J Am Soc Nephrol. 2008 Jan;3(1):36-45. doi: 10.2215/CJN.03591006.
- Results publication: PubMed 19365139Wilkie M, Pontoriero G, Macario F, Yaqoob M, Bouman K, Braun J, von Albertini B, Brink H, Maduell F, Graf H, Frazao JM, Bos WJ, Torregrosa V, Saha H, Reichel H, Zani VJ, Carter D, Messa P. Impact of vitamin D dose on biochemical parameters in patients with secondary hyperparathyroidism receiving cinacalcet. Nephron Clin Pract. 2009;112(1):c41-50. doi: 10.1159/000212102. Epub 2009 Apr 10.
- Derived from this study: PubMed 22863242Frazao JM, Braun J, Messa P, Dehmel B, Mattin C, Wilkie M. Is serum phosphorus control related to parathyroid hormone control in dialysis patients with secondary hyperparathyroidism? BMC Nephrol. 2012 Aug 3;13:76. doi: 10.1186/1471-2369-13-76.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- FDA-approved Drug LabelingLink 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 4 study testing cinacalcet in people with 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?
The sponsor lists 3 inclusion and 6 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 7 Mar 2011. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 7 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?
Number of Participants With Mean PTH ≤ 300 pg/mL (time frame: Efficacy Assessment Phase (weeks 17 to 23)). 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 NCT00110890, which also lists 3 linked publications.
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 7 Mar 2011.