Clinical trial NCT00803712: 20070360 Incident Dialysis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Secondary Hyperparathyroidism
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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).

Primary outcomes:
measure: Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
timeFrame: Weeks 22-26
Secondary outcomes:
measure: Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
timeFrame: Weeks 22-26
measure: Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
timeFrame: Weeks 48-52
measure: Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
timeFrame: Weeks 48-52
measure: Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
timeFrame: Weeks 22-26
measure: Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
timeFrame: Weeks 48-52
measure: Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
timeFrame: Weeks 22-26
measure: Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
timeFrame: Weeks 48-52
measure: 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)
timeFrame: Weeks 22-26 and Weeks 48-52
measure: 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)
timeFrame: Weeks 22-26 and Weeks 48-52
measure: 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)
timeFrame: Weeks 22-26 and Weeks 48-52
measure: 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)
timeFrame: Weeks 22-26 and Weeks 48-52
measure: Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase
timeFrame: Weeks 22-26
measure: Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase
timeFrame: Weeks 22-26
measure: Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase
timeFrame: Weeks 48-52
measure: Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase
timeFrame: Weeks 48-52
measure: Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase
timeFrame: Weeks 22-26
measure: Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase
timeFrame: Weeks 22-26
measure: Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase
timeFrame: Weeks 48-52
measure: Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase
timeFrame: Weeks 48-52
measure: Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase
timeFrame: Weeks 22-26
measure: Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase
timeFrame: Weeks 22-26
measure: Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase
timeFrame: Weeks 48-52
measure: Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase
timeFrame: Weeks 48-52
measure: Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6
timeFrame: Weeks 22-26
measure: Subject Incidence of Hypercalcemia During the Maintenance Phase
timeFrame: Weeks 26-48
measure: Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12
timeFrame: Weeks 48-52
measure: Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6
timeFrame: Weeks 22-26
measure: Subject Incidence of Hyperphosphatemia During the Maintenance Phase
timeFrame: Weeks 26-48
measure: Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12
timeFrame: Weeks 48-52
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Rodriguez M, Urena-Torres P, Petavy F, Cooper K, Farouk M, Goodman WG. Calcium-mediated parathyroid hormone suppression to assess progression of secondary hyperparathyroidism during treatment among incident dialysis patients. J Clin Endocrinol Metab. 2013 Feb;98(2):618-25. doi: 10.1210/jc.2012-3246. Epub 2013 Jan 30.
citation: Urena-Torres P, Bridges I, Christiano C, Cournoyer SH, Cooper K, Farouk M, Kopyt NP, Rodriguez M, Zehnder D, Covic A. Efficacy of cinacalcet with low-dose vitamin D in incident haemodialysis subjects with secondary hyperparathyroidism. Nephrol Dial Transplant. 2013 May;28(5):1241-54. doi: 10.1093/ndt/gfs568. Epub 2013 Jan 16.