AnemiaPhase 4NCT00431496
A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD)
A Phase 4 study testing Cinacalcet in people with Anemia and Secondary Hyperparathyroidism, run by Amgen.
Trial summary
The purpose of this study is to show that the use of cinacalcet in patients with End Stage Renal Disease can help achieve NKF K/DOQI targets for both serum calcium and calcium phosphorous product. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Secondary Hyperparathyroidism
- What is being tested?
- Cinacalcet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Oct 2009
- 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
- Patients with ESRD requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month
- Being treated with Aranesp for anaemia management and have stabilised haemoglobin (Hb) levels. Hb stabilisation is defined as two consecutive Hb measurements during the screening period (that must include the most recent assessment) above 110 g/L.
- Males or females > 18 years of age at the time of informed consent
- Patients participating in this study must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study. Females must have a negative serum pregnancy test within 21 days before day 1 if they are of child-bearing potential
- The mean of 2 Intact parathyroid hormone (iPTH) determinations within 21 days before study day 1 and drawn at least 2 days apart must be > 31.8 pmol/L (300 pg/mL) and < 84.8 pmol/L (800 pg/mL)
- The mean of 2 serum calcium determinations (corrected for albumin) drawn on the same day as the PTH determinations must be > 2.1 mmol/L (8.4 mg/dL)
- Signed the Independent Ethics Committee (IEC) approved Informed Consent document, before ANY study specific procedures are initiated
Who cannot join
- 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 patients are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for the 21 days before day 1
- 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
- Hypersensitivity to Sensipar or any of its components
- Are currently breastfeeding
- Have had a parathyroidectomy in the 3 months before day 1
- Experienced a myocardial infarction within 3 months prior to day 1
Show all 11Show fewer
- Have had a red blood cell transfusion 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 of orally administered medications or an inability to swallow tablets
- Have a disorder that would interfere with understanding and giving informed consent, or compliance with protocol requirements
- Have previously enrolled in this study or participated in other trials of Sensipar
About this study
Official title: A Study To Assess Achievement of NKF K/DOQI Targets Using Sensipar (Cinacalcet) in Australian Subjects With End Stage Renal Disease (ESRD) Who Are Being Treated With Aranesp for Anaemia Management
The purpose of this study is to show that the use of cinacalcet in patients with End Stage Renal Disease can help achieve NKF K/DOQI targets for both serum calcium and calcium phosphorous product.
- Conditions
- Anemia, Secondary Hyperparathyroidism
- Being tested
- Cinacalcet
- Keywords
- Anemia, Intact Parathyroid Hormone (iPTH), Secondary Hyperparathyroidism (SHPT)
- Medical subject headings
- Anemia, Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinacalcetDrug
Also called Sensipar®
Cinacalcet tablets
| Study group | Role | What they receive |
|---|---|---|
| Cinacalcet | Experimental | Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks. Possible sequential doses during the study were 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet occurred if the intact parathyroid hormone (iPTH) level from the previous study visit was > 31.8 pmol/L (300 pg/mL) unless the participant had either reached the maximum dose (180 mg/day), the serum corrected total calcium was < 2.1 mmol/L (8.4 mg/dL), or the participant experienced an adverse event that precluded a dose increase. Receives: Drug: Cinacalcet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2
The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) recommends that treatment interventions to control parathyroid hormone should not result in significant elevation of calcium - phosphorus product (Ca x P; a derived value calculated from serum calcium and phosphorus levels). The primary objective of the study was to assess the simultaneous achievement of NKF K/DOQI targets of intact parathyroid hormone (iPTH) greater than or equal to 15.9 pmol/L and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) and a Ca x P value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) during the effectiveness assessment phase.
Measured: Weeks 17 to 23
Secondary outcomes (5)
Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL
Number of participants who achieved a mean intact Parathyroid Hormone (iPTH) value greater than or equal to 15.9 and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) during the effectiveness assessment phase.
Measured: Weeks 17 to 23
Number of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol^2/L^2 (55 mg^2/dL^2)
The number of participants who achieved a mean serum calcium x phosphorus (Ca x P) value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) during the effectiveness assessment phase. The calcium - phosphorus product is a derived value calculated from serum calcium and phosphorus levels.
Measured: Weeks 17 to 23
Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L
The number of participants who achieved a mean corrected serum calcium (Ca) value ≥ 2.1 and ≤ 2.37 mmol/L (8.4 to 9.5 mg/dL) during the effectiveness assessment phase.
Measured: Weeks 17 to 23
Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L
The number of participants who achieved a mean serum phosphorus value ≥ 1.13 and ≤ 1.78 mmol/L (3.5 to 5.5 mg/dL) during the effectiveness assessment phase.
Measured: Weeks 17 to 23
Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL
The number of participants who achieved a mean C-reactive protein (CRP) level of < 0.6 mg/dL during the effectiveness assessment phase.
Measured: 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 posted5 Feb 2007 (estimated)
- Study startSep 2006
- Primary completionJun 2009
- Study completionOct 2009
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.
- Other trials for AnemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431496
- Sponsor's protocol ID
- 20040196
- Other IDs
- To Target
- Status last verified
- Apr 2013
- First submitted
- 1 Feb 2007
- Last updated
- 24 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study To Assess Achievement of NKF K/DOQI Targets Using Sensipar (Cinacalcet) in Australian Subjects With End Stage Renal Disease (ESRD) Who Are Being Treated With Aranesp for Anaemia Management
- ClinicalTrials.gov ID
- NCT00431496
- Acronym / sponsor ID
- 20040196
- Conditions
- Anemia, Secondary Hyperparathyroidism
- Keywords
- Anemia, Intact Parathyroid Hormone (iPTH), Secondary Hyperparathyroidism (SHPT)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 5 Feb 2007 (estimated)
- Results
- Posted 13 Jul 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 show that the use of cinacalcet in patients with End Stage Renal Disease can help achieve NKF K/DOQI targets for both serum calcium and calcium phosphorous product.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cinacalcet | Experimental | Drug: CinacalcetCinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks. Possible sequential doses during the study were 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet occurred if the intact parathyroid hormone (iPTH) level from the previous study visit was > 31.8 pmol/L (300 pg/mL) unless the participant had either reached the maximum dose (180 mg/day), the serum corrected total calcium was < 2.1 mmol/L (8.4 mg/dL), or the participant experienced an adverse event that precluded a dose increase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with ESRD requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month
- Being treated with Aranesp for anaemia management and have stabilised haemoglobin (Hb) levels. Hb stabilisation is defined as two consecutive Hb measurements during the screening period (that must include the most recent assessment) above 110 g/L.
- Males or females > 18 years of age at the time of informed consent
- Patients participating in this study must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study. Females must have a negative serum pregnancy test within 21 days before day 1 if they are of child-bearing potential
- The mean of 2 Intact parathyroid hormone (iPTH) determinations within 21 days before study day 1 and drawn at least 2 days apart must be > 31.8 pmol/L (300 pg/mL) and < 84.8 pmol/L (800 pg/mL)
Key exclusion criteria (11 listed)
- 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 patients are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for the 21 days before day 1
- 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
- Hypersensitivity to Sensipar or any of its components
- Are currently breastfeeding
- Have had a parathyroidectomy in the 3 months before day 1
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 |
|---|---|---|
| CinacalcetAlso: Sensipar®Cinacalcet tablets | Drug | Cinacalcet |
Primary outcome
Number of Participants With a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2
Time frame: Weeks 17 to 23
The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) recommends that treatment interventions to control parathyroid hormone should not result in significant elevation of calcium - phosphorus product (Ca x P; a derived value calculated from serum calcium and phosphorus levels). The primary objective of the study was to assess the simultaneous achievement of NKF K/DOQI targets of intact parathyroid hormone (iPTH) greater than or equal to 15.9 pmol/L and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) and a Ca x P value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) during the effectiveness assessment phase.
5 secondary outcomes
Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL
Time frame: Weeks 17 to 23
Number of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol^2/L^2 (55 mg^2/dL^2)
Time frame: Weeks 17 to 23
Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L
Time frame: Weeks 17 to 23
Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L
Time frame: Weeks 17 to 23
Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL
Time frame: 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 24 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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 Anemia and Secondary Hyperparathyroidism, 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 7 inclusion and 11 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 24 Apr 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. 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 13 Jul 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 a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2 (time frame: Weeks 17 to 23). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2013.