Back to resultsA 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)
Primary Purpose
Anemia, Secondary Hyperparathyroidism
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cinacalcet
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring Anemia, Intact Parathyroid Hormone (iPTH), Secondary Hyperparathyroidism (SHPT)
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cinacalcet
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00431496
Brief Title
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)
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Secondary Hyperparathyroidism
Keywords
Anemia, Intact Parathyroid Hormone (iPTH), Secondary Hyperparathyroidism (SHPT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cinacalcet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cinacalcet
Other Intervention Name(s)
Sensipar®
Intervention Description
Cinacalcet tablets
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Weeks 17 to 23
Secondary Outcome Measure Information:
Title
Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL
Description
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.
Time Frame
Weeks 17 to 23
Title
Number of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol^2/L^2 (55 mg^2/dL^2)
Description
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.
Time Frame
Weeks 17 to 23
Title
Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L
Description
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.
Time Frame
Weeks 17 to 23
Title
Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L
Description
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.
Time Frame
Weeks 17 to 23
Title
Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL
Description
The number of participants who achieved a mean C-reactive protein (CRP) level of < 0.6 mg/dL during the effectiveness assessment phase.
Time Frame
Weeks 17 to 23
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
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)
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