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Study Complete
Sponsor ID
20070360

20070360 Incident Dialysis

Sponsor ID
20070360
Clinicaltrials.gov ID
NCT00803712
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 4
Product
cinacalcet hcl
Type
Interventional
Masking
None (Open Label)
Enrollment
313
Additional Study Details

Protocol Summary

Primary Outcome Measures

Achievement of a 30% reduction in mean PTH from baseline to during the efficacy assessment phase at month 6 (weeks 22 to 26)

Timeframe: From Baseline to during the efficacy assessment phase at month 6 (weeks 22 to 26)

Secondary Outcome Measures

Achievement within the specified treatment targets for PTH; Ca; and P during the efficacy assessment phase at month 6 (weeks 22 to 26)

Timeframe: During the efficacy assessment phase at month 6 (weeks 22 to 26)

Achievement of a greater than or equal to 30% reduction in mean PTH from baseline to during the efficacy assessment phase at month 12 (weeks 48 to 52)

Timeframe: Baseline to during the efficacy assessment phase at month 12 (weeks 48 to 52)

Achievement within the specified treatment targets for PTH; Ca; and P during the efficacy assessment phase at month 12 (weeks 48 to 52)

Timeframe: During the efficacy assessment phase at month 12 (weeks 48 to 52)

Achievement of a greater than or equal to 30% reduction in mean PTH from baseline to during both efficacy assessment phases at month 6 (weeks 22 to 26) and month 12 (weeks 48 to 52)

Timeframe: From baseline to during both efficacy assessment phases at month 6 (weeks 22 to 26) and month 12 (weeks 48 to 52)

Achievement within the specified treatment targets for PTH; Ca; and P during both efficacy assessment phases at month 6 (weeks 22 to 26) and month 12 (weeks 48 to 52)

Timeframe: During both efficacy assessment phases at month 6 (weeks 22 to 26) and month 12 (weeks 48 to 52)

Absolute values and percent changes from baseline for PTH, Ca, and P

Timeframe: The efficacy assessment phase at month 6 (weeks 22 to 26) and the efficacy assessment phase at month 12 (weeks 48 to 52)

Subject incidence of acute episodes of hypercalcemia / hyperphosphatemia

Timeframe: The efficacy assessment phase at month 6 (weeks 22 to 26), the maintenance phase and the efficacy assessment phase at month 12 (weeks 48 to 52)

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

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Study Info
Age
18+ years
Condition
  • Kidney Disease
    • Show more
  • Hyperparathyroidism
    • Sex
    All
    Trial Dates
    Feb 2009 - Dec 2010
    Inclusion and Exclusion 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).