Phase 4
N=309
20070360 Incident Dialysis
Chronic Kidney Disease · Secondary Hyperparathyroidism
Bottom Line
View on ClinicalTrials.gov: NCT00803712 ↗Enrolled (actual)
309
Serious AEs
40.1%
Results posted
Mar 2014
Primary outcome: Primary: Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) — 96; 58; 57; 93 participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cinacalcet (Drug); Vitamin D (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) |
96; 58; 57; 93 | <0.0001 sig |
| SECONDARY Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) |
87; 53; 66; 98 | 0.0002 sig |
| SECONDARY Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) |
97; 72; 56; 79 | 0.0139 sig |
| SECONDARY Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) |
80; 67; 73; 84 | 0.2386 |
| SECONDARY Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) |
151; 144; 2; 7 | 0.0875 |
| SECONDARY Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) |
146; 141; 7; 10 | 0.4304 |
| SECONDARY Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) |
100; 85; 53; 66 | 0.0910 |
| SECONDARY Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52) |
81; 80; 72; 71 | 0.9520 |
| SECONDARY 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) |
74; 42; 79; 109 | 0.0003 sig |
| SECONDARY 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) |
54; 39; 99; 112 | 0.0611 |
| SECONDARY 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) |
145; 139; 8; 12 | 0.3298 |
| SECONDARY 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) |
71; 64; 82; 87 | 0.4436 |
| SECONDARY Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase |
291.15; 402.11 | <0.0001 sig |
| SECONDARY Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase |
-34.62; -9.69 | <0.0001 sig |
| SECONDARY Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase |
293.95; 364.79 | 0.0040 sig |
| SECONDARY Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase |
-34.15; -12.41 | <0.0001 sig |
| SECONDARY Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase |
8.66; 9.30 | <0.0001 sig |
| SECONDARY Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase |
-5.68; 1.05 | <0.0001 sig |
| SECONDARY Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase |
8.95; 9.42 | <0.0001 sig |
| SECONDARY Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase |
-2.62; 2.37 | <0.0001 sig |
| SECONDARY Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase |
5.11; 5.52 | 0.0085 sig |
| SECONDARY Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase |
-1.79; 3.94 | 0.0710 |
| SECONDARY Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase |
5.37; 5.53 | 0.3546 |
| SECONDARY Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase |
3.21; 4.26 | 0.7518 |
| SECONDARY Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6 |
11; 22 | — |
| SECONDARY Subject Incidence of Hypercalcemia During the Maintenance Phase |
16; 25 | — |
| SECONDARY Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12 |
15; 21 | — |
| SECONDARY Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6 |
71; 93 | — |
| SECONDARY Subject Incidence of Hyperphosphatemia During the Maintenance Phase |
71; 87 | — |
| SECONDARY Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12 |
74; 83 | — |
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).
Data sourced from ClinicalTrials.gov (NCT00803712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.