Trial Outcomes & Findings for Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis (NCT NCT01181531)

NCT ID: NCT01181531

Last Updated: 2018-10-17

Results Overview

Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

312 participants

Primary outcome timeframe

Baseline to week 40-52

Results posted on

2018-10-17

Participant Flow

Participants were enrolled from 08 September 2010 through 14 August 2012 Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.

Participant milestones

Participant milestones
Measure	Traditional Vitamin D Vitamin D sterol, intravenous (IV) or oral	Cinacalcet Cinacalcet Hydrochloride (Sensipar)
Overall Study STARTED	157	155
Overall Study Received Investigational Product	155	153
Overall Study COMPLETED	96	102
Overall Study NOT COMPLETED	61	53

Reasons for withdrawal

Reasons for withdrawal
Measure	Traditional Vitamin D Vitamin D sterol, intravenous (IV) or oral	Cinacalcet Cinacalcet Hydrochloride (Sensipar)
Overall Study Other	17	12
Overall Study Partial consent by subject withdrawn	0	1
Overall Study Physician Decision	3	1
Overall Study Noncompliance	2	2
Overall Study Ineligibility determined	1	2
Overall Study Protocol Specified Criteria	15	8
Overall Study Pregnancy	0	1
Overall Study Withdrawal by Subject	8	7
Overall Study Protocol Violation	6	6
Overall Study Death	9	12
Overall Study Adverse Event	0	1

Baseline Characteristics

Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Traditional Vitamin D n=157 Participants Vitamin D sterol, intravenous (IV) or oral	Cinacalcet n=155 Participants Cinacalcet Hydrochloride (Sensipar)	Total n=312 Participants Total of all reporting groups
Age, Continuous	54.3 years STANDARD_DEVIATION 13.9 • n=99 Participants	53.5 years STANDARD_DEVIATION 14.5 • n=107 Participants	53.9 years STANDARD_DEVIATION 14.2 • n=206 Participants
Sex: Female, Male Female	62 Participants n=99 Participants	62 Participants n=107 Participants	124 Participants n=206 Participants
Sex: Female, Male Male	95 Participants n=99 Participants	93 Participants n=107 Participants	188 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	47 Participants n=99 Participants	32 Participants n=107 Participants	79 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	110 Participants n=99 Participants	123 Participants n=107 Participants	233 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=99 Participants	0 participants n=107 Participants	1 participants n=206 Participants
Race/Ethnicity, Customized Asian	4 participants n=99 Participants	8 participants n=107 Participants	12 participants n=206 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 participants n=99 Participants	0 participants n=107 Participants	1 participants n=206 Participants
Race/Ethnicity, Customized Black or African American	60 participants n=99 Participants	76 participants n=107 Participants	136 participants n=206 Participants
Race/Ethnicity, Customized White	86 participants n=99 Participants	66 participants n=107 Participants	152 participants n=206 Participants
Race/Ethnicity, Customized More than one race	4 participants n=99 Participants	5 participants n=107 Participants	9 participants n=206 Participants
Race/Ethnicity, Customized Unknown or Not Reported	1 participants n=99 Participants	0 participants n=107 Participants	1 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline to week 40-52

Population: All subjects randomized by treatment arm.

Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52

Outcome measures

Outcome measures
Measure	Traditional Vitamin D n=157 Participants Vitamin D sterol, intravenous (IV) or oral	Cinacalcet n=155 Participants Cinacalcet Hydrochloride
Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)	-7 Percent change Standard Error 4.0	-12.1 Percent change Standard Error 4.0

SECONDARY outcome

Timeframe: Baseline to week 40-52

Number of participants achieving a \>=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)

Outcome measures

Outcome measures
Measure	Traditional Vitamin D n=157 Participants Vitamin D sterol, intravenous (IV) or oral	Cinacalcet n=155 Participants Cinacalcet Hydrochloride
Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP) Yes	53 Participants	66 Participants
Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP) No	104 Participants	89 Participants

SECONDARY outcome

Timeframe: week 40-52

Number of participants achieving Plasma PTH \< 300 pg/mL During Efficacy Assessment Phase (EAP)

Outcome measures

Outcome measures
Measure	Traditional Vitamin D n=157 Participants Vitamin D sterol, intravenous (IV) or oral	Cinacalcet n=155 Participants Cinacalcet Hydrochloride
Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP) Yes	24 Participants	30 Participants
Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP) No	133 Participants	125 Participants

Adverse Events

Traditional Vitamin D

Serious events: 68 serious events

Other events: 83 other events

Deaths: 0 deaths

Cinacalcet

Serious events: 60 serious events

Other events: 98 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	Traditional Vitamin D n=155 participants at risk Vitamin D sterol, intravenous (IV) or oral	Cinacalcet n=153 participants at risk Cinacalcet Hydrochloride (Sensipar)
Blood and lymphatic system disorders Anaemia	3.2% 5/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	2.6% 4/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Endocrine disorders Hyperparathyroidism	3.2% 5/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	1.3% 2/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Gastrointestinal disorders Abdominal pain	0.65% 1/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	3.3% 5/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Gastrointestinal disorders Constipation	4.5% 7/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	5.2% 8/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Gastrointestinal disorders Diarrhoea	10.3% 16/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	9.8% 15/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Gastrointestinal disorders Nausea	6.5% 10/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	17.6% 27/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Gastrointestinal disorders Vomiting	3.2% 5/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	10.5% 16/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
General disorders Asthenia	0.65% 1/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	4.6% 7/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
General disorders Chest pain	3.2% 5/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	3.9% 6/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
General disorders Oedema	3.2% 5/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	1.3% 2/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
General disorders Oedema peripheral	3.2% 5/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	5.2% 8/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
General disorders Pain	1.3% 2/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	3.9% 6/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
General disorders Pyrexia	5.2% 8/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	2.0% 3/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Infections and infestations Urinary tract infection	1.9% 3/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	3.3% 5/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	4.5% 7/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	5.2% 8/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Injury, poisoning and procedural complications Fall	2.6% 4/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	4.6% 7/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Injury, poisoning and procedural complications Procedural hypotension	4.5% 7/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	2.6% 4/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Injury, poisoning and procedural complications Vascular graft thrombosis	2.6% 4/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	3.9% 6/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Metabolism and nutrition disorders Decreased appetite	3.2% 5/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	2.0% 3/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Metabolism and nutrition disorders Fluid overload	5.2% 8/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	1.3% 2/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Metabolism and nutrition disorders Hypercalcaemia	4.5% 7/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	0.65% 1/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Metabolism and nutrition disorders Hyperkalaemia	2.6% 4/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	3.9% 6/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Metabolism and nutrition disorders Hyperphosphataemia	4.5% 7/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	2.0% 3/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Metabolism and nutrition disorders Hypocalcaemia	1.3% 2/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	17.0% 26/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Musculoskeletal and connective tissue disorders Arthralgia	4.5% 7/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	3.9% 6/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Musculoskeletal and connective tissue disorders Back pain	4.5% 7/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	2.0% 3/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Musculoskeletal and connective tissue disorders Muscle spasms	9.0% 14/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	7.8% 12/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Musculoskeletal and connective tissue disorders Pain in extremity	3.9% 6/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	6.5% 10/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Nervous system disorders Dizziness	3.2% 5/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	4.6% 7/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Nervous system disorders Headache	2.6% 4/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	5.2% 8/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Psychiatric disorders Anxiety	5.2% 8/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	2.6% 4/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Psychiatric disorders Insomnia	3.9% 6/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	5.2% 8/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Respiratory, thoracic and mediastinal disorders Cough	6.5% 10/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	5.9% 9/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.2% 8/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	11.1% 17/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Vascular disorders Hypertension	4.5% 7/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	5.2% 8/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Vascular disorders Hypotension	3.9% 6/155 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.	5.9% 9/153 • 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.