Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
- Conditions
- Chronic Kidney DiseaseSecondary HyperparathyroidismHemodialysis
- Interventions
- Registration Number
- NCT00977080
- Lead Sponsor
- Abbott
- Brief Summary
Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.
- Detailed Description
During a 4-week washout period, participants stopped taking cinacalcet or other vitamin D receptor activators (VDRAs). (Participants who were naive to cinacalcet or VDRAs did not have to wash out). At randomization, participants entered a 28-week open-label treatment period, during which they received either cinacalcet or paricalcitol. Participants who were assigned to receive paricalcitol were dosed according to the approved label in their respective geographic regions (i.e., IV at sites in the US and Russia and oral at sites in Europe). Supplemental cinacalcet was administered to participants in the paricalcitol arms who developed hypercalcemia (defined as \>= 10.5 mg/dL). The evaluation period was from Weeks 21 to 28.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 272
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IV Paricalcitol Paricalcitol Participants in the IV stratum received intravenous (IV) paricalcitol and, if hypercalcemia (calcium \>= 10.5 mg/dL), received 30 mg of oral cinacalcet. Paricalcitol was dosed at 0.07 mcg/kg with titration every 2 weeks. Cinacalcet (at sites with IV paricalcitol) Cinacalcet Participants in the IV stratum received 30 mg of oral cinacalcet daily with a low-dose vitamin D receptor activator (VDRA) (doxercalciferol IV 1 mcg 3 times weekly (TIW) at sites in the US and alfacalcidol capsules 0.25 mcg daily at sites in Russia). Oral paricalcitol Paricalcitol Participants in the oral stratum received oral paricalcitol and, if hypercalcemia (calcium \>= 10.5 mg/dL), received 30 mg of oral cinacalcet. Paricalcitol was dosed at mcg = IPTH/60 3 times weekly (TIW) with titration every 2 weeks. Cinacalcet (at sites with oral paricalcitol) Cinacalcet Participants in the oral stratum received 30 mg of oral cinacalcet daily with a low-dose vitamin D receptor activator (VDRA) (alfacalcidol capsules 0.25 mcg daily).
- Primary Outcome Measures
Name Time Method The Number of Participants Who Achieve a Mean Intact Parathyroid Hormone (iPTH) Value Between 150 to 300 pg/mL During the Evaluation Period (Weeks 21 to 28). Weeks 21 to 28 iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Achieve at Least 30% Reduction From Baseline in Intact Parathyroid Hormone (iPTH) as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28). Weeks 21 to 28 iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 30% reduction from Baseline were counted.
Number of Participants Who Achieve at Least 50% Reduction From Baseline in iPTH as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28). Weeks 21 to 28 iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 50% reduction from Baseline were counted.
Analysis of the Number of Participants Who Achieve a Mean iPTH Value Between 150 and 300 pg/mL During the Evaluation Period (Weeks 21 to 28) Using a Cochran-Mantel-Haenszel Test Controlling for IV and Oral Site Randomization Strata Weeks 21 to 28 iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted. Data from both the IV and oral strata were analyzed together.
Number of Participants With Hypocalcemia Defined as < 8.4 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28) Weeks 21 to 28 Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was \< 8.4 mg/dL were counted.
Number of Participants With Hypercalcemia Defined as Calcium > 10.5 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28) Weeks 21 to 28 Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was \> 10.5 mg/dL were counted.
Trial Locations
- Locations (83)
Site Reference ID/Investigator# 22781
🇺🇸Tempe, Arizona, United States
Site Reference ID/Investigator# 21144
🇺🇸St. Louis, Missouri, United States
Site Reference ID/Investigator# 22770
🇺🇸Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 22464
🇵🇹Lisbon, Portugal
Site Reference ID/Investigator# 21142
🇺🇸Los Angeles, California, United States
Site Reference ID/Investigator# 21443
🇺🇸St. Louis, Missouri, United States
Site Reference ID/Investigator# 22778
🇺🇸Meridian, Idaho, United States
Site Reference ID/Investigator# 22759
🇺🇸Toledo, Ohio, United States
Site Reference ID/Investigator# 23688
🇺🇸Arvada, Colorado, United States
Site Reference ID/Investigator# 25902
🇺🇸Hudson, Florida, United States
Site Reference ID/Investigator# 21146
🇺🇸Lauderdale Lakes, Florida, United States
Site Reference ID/Investigator# 23147
🇺🇸Tampa, Florida, United States
Site Reference ID/Investigator# 22722
🇺🇸Orlando, Florida, United States
Site Reference ID/Investigator# 22796
🇺🇸Lancaster, Pennsylvania, United States
Site Reference ID/Investigator# 23105
🇩🇰Copenhagen, Denmark
Site Reference ID/Investigator# 21746
🇮🇹Genova, Italy
Site Reference ID/Investigator# 22314
🇮🇹Milan, Italy
Site Reference ID/Investigator# 22762
🇺🇸Los Angeles, California, United States
Site Reference ID/Investigator# 21442
🇺🇸San Diego, California, United States
Site Reference ID/Investigator# 21370
🇺🇸Coral Springs, Florida, United States
Site Reference ID/Investigator# 26743
🇺🇸Lauderdale Lakes, Florida, United States
Site Reference ID/Investigator# 22788
🇺🇸Miami, Florida, United States
Site Reference ID/Investigator# 22758
🇺🇸Riverside, California, United States
Site Reference ID/Investigator# 22772
🇺🇸Aiken, South Carolina, United States
Site Reference ID/Investigator# 21143
🇺🇸Houston, Texas, United States
Site Reference ID/Investigator# 22505
🇺🇸Flushing, New York, United States
Site Reference ID/Investigator# 35903
🇩🇪Duesseldorf, Germany
Site Reference ID/Investigator# 22982
🇺🇸Houston, Texas, United States
Site Reference ID/Investigator# 21365
🇪🇸Seville, Spain
Site Reference ID/Investigator# 23104
🇬🇧London, United Kingdom
Site Reference ID/Investigator# 23103
🇬🇧Manchester, United Kingdom
Site Reference ID/Investigator# 23912
🇬🇧Birmingham, United Kingdom
Site Reference ID/Investigator# 41982
🇬🇧Omagh, Northern Ireland, United Kingdom
Site Reference ID/Investigator# 21145
🇺🇸Omaha, Nebraska, United States
Site Reference ID/Investigator# 24342
🇺🇸Chula Vista, California, United States
Site Reference ID/Investigator# 21368
🇩🇪Luedenscheid, Germany
Site Reference ID/Investigator# 22363
🇩🇰Aalborg, Denmark
Site Reference ID/Investigator# 22311
🇨🇿Brno, Czech Republic
Site Reference ID/Investigator# 22310
🇨🇿Jilemnice, Czech Republic
Site Reference ID/Investigator# 22776
🇺🇸Bluefield, West Virginia, United States
Site Reference ID/Investigator# 21624
🇨🇿Usti nad Labem, Czech Republic
Site Reference ID/Investigator# 22462
🇩🇰Holstebro, Denmark
Site Reference ID/Investigator# 21748
🇩🇪Coburg, Germany
Site Reference ID/Investigator# 33268
🇩🇪Darmstadt, Germany
Site Reference ID/Investigator# 23909
🇩🇰Fredericia, Denmark
Site Reference ID/Investigator# 21742
🇩🇪Frankfurt, Germany
Site Reference ID/Investigator# 21744
🇩🇪Heilbronn, Germany
Site Reference ID/Investigator# 22362
🇬🇷Athens, Greece
Site Reference ID/Investigator# 38970
🇬🇷Thessaloniki, Greece
Site Reference ID/Investigator# 22463
🇬🇷Thessaloniki, Greece
Site Reference ID/Investigator# 22322
🇬🇷Thessaloniki, Greece
Site Reference ID/Investigator# 21745
🇮🇹Pesaro, Italy
Site Reference ID/Investigator# 39262
🇬🇷Thessaloniki, Greece
Site Reference ID/Investigator# 22312
🇮🇹Bergamo, Italy
Site Reference ID/Investigator# 21367
🇮🇹Pavia, Italy
Site Reference ID/Investigator# 22323
🇬🇷Thessaloniki, Greece
Site Reference ID/Investigator# 39180
🇮🇹Lucca, Italy
Site Reference ID/Investigator# 21842
🇳🇱Alkmaar, Netherlands
Site Reference ID/Investigator# 22309
🇳🇱Delft, Netherlands
Site Reference ID/Investigator# 21843
🇳🇱Dordrecht, Netherlands
Site Reference ID/Investigator# 38531
🇵🇹Faro, Portugal
Site Reference ID/Investigator# 24643
🇷🇺Moscow, Russian Federation
Site Reference ID/Investigator# 38903
🇵🇹Beja, Portugal
Site Reference ID/Investigator# 23910
🇵🇹Vila Franca de Xira, Portugal
Site Reference ID/Investigator# 24642
🇷🇺Moscow, Russian Federation
Site Reference ID/Investigator# 21364
🇪🇸Cordoba, Spain
Site Reference ID/Investigator# 21361
🇪🇸Barcelona, Spain
Site Reference ID/Investigator# 22366
🇪🇸L'Hospitalet, Barcelona, Spain
Site Reference ID/Investigator# 38343
🇪🇸Madrid, Spain
Site Reference ID/Investigator# 21362
🇪🇸Madrid, Spain
Site Reference ID/Investigator# 22364
🇸🇪Uppsala, Sweden
Site Reference ID/Investigator# 21747
🇬🇧Coventry, United Kingdom
Site Reference ID/Investigator# 21363
🇪🇸Palma de Mallorca, Spain
Site Reference ID/Investigator# 23782
🇸🇪Stockholm, Sweden
Site Reference ID/Investigator# 23913
🇸🇪Linkoping, Sweden
Site Reference ID/Investigator# 22367
🇪🇸Pamplona, Spain
Site Reference ID/Investigator# 38462
🇪🇸Puerto de la Cruz, Spain
Site Reference ID/Investigator# 23102
🇬🇧London, United Kingdom
Site Reference ID/Investigator# 40222
🇬🇧Sheffield, United Kingdom
Site Reference ID/Investigator# 21369
🇺🇸Detroit, Michigan, United States
Site Reference ID/Investigator# 22786
🇺🇸Detroit, Michigan, United States
Site Reference ID/Investigator# 21147
🇺🇸Orangeburg, South Carolina, United States
Site Reference ID/Investigator# 22506
🇺🇸San Antonio, Texas, United States