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20070360 Incident Dialysis

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ClinicalTrials.gov Identifier: NCT00803712
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : March 12, 2014
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Secondary Hyperparathyroidism Drug: Cinacalcet Drug: Vitamin D Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 313 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination With Low Dose Vitamin D for the Treatment of Subjects With Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis
Actual Study Start Date : February 1, 2009
Actual Primary Completion Date : December 9, 2010
Actual Study Completion Date : July 5, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Vitamin D

Arm Intervention/treatment
Experimental: Cinacalcet Group
Cinacalcet plus low dose active Vitamin D (if prescribed)
Drug: Cinacalcet
Cinacalcet is a calcimimetic agent, which is synthesized as a hydrochloride salt.
Other Name: Sensipar/Mimpara

Active Comparator: Control Group
Flexible active vitamin D dosing
Drug: Vitamin D
Titration of active Vitamin D in accordance with treatment practice guidelines in order to treat Secondary Hyperparathyroidism.
Other Name: Active Vitamin D




Primary Outcome Measures :
  1. Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) [ Time Frame: Weeks 22-26 ]
    All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.


Secondary Outcome Measures :
  1. Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) [ Time Frame: Weeks 22-26 ]
    All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  2. Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) [ Time Frame: Weeks 48-52 ]
    All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  3. Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) [ Time Frame: Weeks 48-52 ]
    All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  4. Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) [ Time Frame: Weeks 22-26 ]
    All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  5. Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) [ Time Frame: Weeks 48-52 ]
    All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  6. Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) [ Time Frame: Weeks 22-26 ]
    All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  7. Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) [ Time Frame: Weeks 48-52 ]
    All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  8. Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) [ Time Frame: Weeks 22-26 and Weeks 48-52 ]
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  9. Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) [ Time Frame: Weeks 22-26 and Weeks 48-52 ]
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  10. Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) [ Time Frame: Weeks 22-26 and Weeks 48-52 ]
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  11. Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52) [ Time Frame: Weeks 22-26 and Weeks 48-52 ]
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  12. Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase [ Time Frame: Weeks 22-26 ]
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  13. Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase [ Time Frame: Weeks 22-26 ]
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  14. Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase [ Time Frame: Weeks 48-52 ]
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  15. Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase [ Time Frame: Weeks 48-52 ]
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  16. Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase [ Time Frame: Weeks 22-26 ]
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  17. Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase [ Time Frame: Weeks 22-26 ]
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  18. Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase [ Time Frame: Weeks 48-52 ]
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  19. Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase [ Time Frame: Weeks 48-52 ]
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  20. Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase [ Time Frame: Weeks 22-26 ]
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  21. Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase [ Time Frame: Weeks 22-26 ]
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  22. Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase [ Time Frame: Weeks 48-52 ]
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  23. Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase [ Time Frame: Weeks 48-52 ]
    All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  24. Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6 [ Time Frame: Weeks 22-26 ]
    Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL

  25. Subject Incidence of Hypercalcemia During the Maintenance Phase [ Time Frame: Weeks 26-48 ]
    Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL

  26. Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12 [ Time Frame: Weeks 48-52 ]
    Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL

  27. Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6 [ Time Frame: Weeks 22-26 ]
    Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL

  28. Subject Incidence of Hyperphosphatemia During the Maintenance Phase [ Time Frame: Weeks 26-48 ]
    Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL

  29. Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12 [ Time Frame: Weeks 48-52 ]
    Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL



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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults greater than or equal to 18 years of age on hemodialysis for > 3 and less than or equal to 12 months prior to enrollment into the study
  • Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 300 pg/mL (31.8 pmol/L); or biPTH > 160 pg/mL (17.0 pmol/L)
  • Mean of 2 corrected serum calcium determinations drawn on the same day as the PTH determinations greater than or equal to 8.4 mg/dL (2.1 mmol/L)
  • Subject will be able to complete the study, to the best of his/her knowledge
  • Before any study-specific procedure, the appropriate written informed consent must be obtained

Exclusion Criteria:

  • Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 800 pg/mL (84.9 pmol/L); or biPTH > 430 pg/mL (45.6 pmol/L) AND receiving vitamin D on entering screening
  • Parathyroidectomy (partial or full) less than or equal to 6 months before entering screening
  • Anticipated parathyroidectomy (partial or full) within 6 months after randomization
  • Have a scheduled date for kidney transplant surgery
  • Received cinacalcet since initiating hemodialysis
  • Have received vitamin D therapy for less than 30 days before entering screening or required a change in prescribed vitamin D brand or dose within 30 days before entering screening. If subjects are not receiving vitamin D therapy, they must remain free of vitamin D therapy for the 30 days before entering screening
  • Subject is pregnant (eg, positive HCG test) or is breast-feeding
  • Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the study (screening and post enrollment)
  • Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets
  • Known sensitivity, intolerance, or other adverse response to cinacalcet which would prevent on-study treatment compliance
  • Have an unstable medical condition within 30 days before screening, or otherwise unstable in the judgment of the investigator
  • Subject is currently enrolled in, or fewer than 30 days prior to entering screening have passed since subject received other investigational agent(s) (devices or drug).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803712


Sponsors and Collaborators
Amgen
Investigators
Layout table for investigator information
Study Director: MD Amgen

Additional Information:
Publications:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00803712     History of Changes
Other Study ID Numbers: 20070360
First Posted: December 5, 2008    Key Record Dates
Results First Posted: March 12, 2014
Last Update Posted: October 17, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Kidney Diseases
Neoplasm Metastasis
Renal Insufficiency, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cinacalcet
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists