Trial Outcomes & Findings for Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients (NCT NCT00042432)
NCT ID: NCT00042432
Last Updated: 2013-05-13
Results Overview
Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Efficacy assessment phase (weeks 12-18)
Results posted on
2013-05-13
Participant Flow
Participants were enrolled from 28 June 2002 through 14 November 2002
Participant milestones
| Measure |
Cinacalcet (AMG 073)
Cinacalcet administered orally once daily with dose titrated starting at 30 mg
|
Placebo
Placebo administered orally once daily
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
Cinacalcet (AMG 073)
Cinacalcet administered orally once daily with dose titrated starting at 30 mg
|
Placebo
Placebo administered orally once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Ineligibility determined
|
1
|
0
|
|
Overall Study
Initiation of maintenance dialysis
|
1
|
1
|
|
Overall Study
Other
|
2
|
0
|
Baseline Characteristics
Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
Baseline characteristics by cohort
| Measure |
Cinacalcet (AMG 073)
n=27 Participants
Cinacalcet administered orally once daily with dose titrated starting at 30 mg
|
Placebo
n=27 Participants
Placebo administered orally once daily
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
60.6 Years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
61.9 Years
STANDARD_DEVIATION 15.2 • n=7 Participants
|
61.2 Years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Glomerular Filtration Rate (GFR) Stratification Factor
GFR ≥ 15 and < 25 ml/min/1.73 m^2
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Glomerular Filtration Rate (GFR) Stratification Factor
GFR ≥ 25 and ≤ 50 ml/min/1.73 m^2
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Intact Parathyroid Hormone (iPTH)
|
243.3 pg/mL
STANDARD_DEVIATION 139.5 • n=5 Participants
|
236.1 pg/mL
STANDARD_DEVIATION 189.5 • n=7 Participants
|
239.7 pg/mL
STANDARD_DEVIATION 164.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Efficacy assessment phase (weeks 12-18)Population: All randomized participants, using Last Value Carried Forward (LVCF) imputation
Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase
Outcome measures
| Measure |
Cinacalcet (AMG 073)
n=27 Participants
Cinacalcet administered orally once daily with dose titrated starting at 30 mg
|
Placebo
n=27 Participants
Placebo administered orally once daily
|
|---|---|---|
|
Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase
|
15 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline, efficacy assessment phase (weeks 12-18)Population: All randomized participants, using Last Value Carried Forward (LVCF) imputation
Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase
Outcome measures
| Measure |
Cinacalcet (AMG 073)
n=27 Participants
Cinacalcet administered orally once daily with dose titrated starting at 30 mg
|
Placebo
n=27 Participants
Placebo administered orally once daily
|
|---|---|---|
|
Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase
|
-31.5 Percent change
Standard Error 6.70
|
5.8 Percent change
Standard Error 6.97
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths
Cinacalcet
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=27 participants at risk
|
Cinacalcet
n=27 participants at risk
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Oedema peripheral
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Sepsis
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Clubbing
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal failure acute
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Placebo
n=27 participants at risk
|
Cinacalcet
n=27 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
3/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.8%
4/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
22.2%
6/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
3/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
33.3%
9/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Toothache
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.8%
4/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Asthenia
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chills
|
11.1%
3/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Fatigue
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Oedema peripheral
|
11.1%
3/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Gastroenteritis
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
3/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
3/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
3/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
3/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
22.2%
6/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.8%
4/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
18.5%
5/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dysgeusia
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.1%
3/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Headache
|
14.8%
4/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Hypoaesthesia
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Paraesthesia
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Tremor
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Insomnia
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.8%
4/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
2/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
3.7%
1/27 • 18 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of 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 after completion. 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 multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER