Trial Outcomes & Findings for A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD) (NCT NCT00431496)
NCT ID: NCT00431496
Last Updated: 2013-04-24
Results Overview
The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) recommends that treatment interventions to control parathyroid hormone should not result in significant elevation of calcium - phosphorus product (Ca x P; a derived value calculated from serum calcium and phosphorus levels). The primary objective of the study was to assess the simultaneous achievement of NKF K/DOQI targets of intact parathyroid hormone (iPTH) greater than or equal to 15.9 pmol/L and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) and a Ca x P value \< 4.44 mmol\^2/L\^2 (55 mg\^2/dL\^2) during the effectiveness assessment phase.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
71 participants
Primary outcome timeframe
Weeks 17 to 23
Results posted on
2013-04-24
Participant Flow
Participants were enrolled from 27 October 2006 through 31 December 2008
Participant milestones
| Measure |
Cinacalcet
Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks. Possible sequential doses during the study were 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet occurred if the intact parathyroid hormone (iPTH) level from the previous study visit was \> 31.8 pmol/L (300 pg/mL), unless the participant had either reached the maximum dose (180 mg/day), the serum corrected total calcium was \< 2.1 mmol/L (8.4 mg/dL), or the participant experienced an adverse event that precluded a dose increase.
|
|---|---|
|
Overall Study
STARTED
|
71
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Cinacalcet
Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks. Possible sequential doses during the study were 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet occurred if the intact parathyroid hormone (iPTH) level from the previous study visit was \> 31.8 pmol/L (300 pg/mL), unless the participant had either reached the maximum dose (180 mg/day), the serum corrected total calcium was \< 2.1 mmol/L (8.4 mg/dL), or the participant experienced an adverse event that precluded a dose increase.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Protocol-specified criteria
|
5
|
Baseline Characteristics
A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD)
Baseline characteristics by cohort
| Measure |
Cinacalcet
n=71 Participants
Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
|
|---|---|
|
Age Continuous
|
62.3 Years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Aborigine
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 17 to 23Population: All participants who received cinacalcet
The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) recommends that treatment interventions to control parathyroid hormone should not result in significant elevation of calcium - phosphorus product (Ca x P; a derived value calculated from serum calcium and phosphorus levels). The primary objective of the study was to assess the simultaneous achievement of NKF K/DOQI targets of intact parathyroid hormone (iPTH) greater than or equal to 15.9 pmol/L and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) and a Ca x P value \< 4.44 mmol\^2/L\^2 (55 mg\^2/dL\^2) during the effectiveness assessment phase.
Outcome measures
| Measure |
Cinacalcet
n=71 Participants
Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
|
|---|---|
|
Number of Participants With a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2
|
30 Participants
|
SECONDARY outcome
Timeframe: Weeks 17 to 23Population: All participants who received cinacalcet
Number of participants who achieved a mean intact Parathyroid Hormone (iPTH) value greater than or equal to 15.9 and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) during the effectiveness assessment phase.
Outcome measures
| Measure |
Cinacalcet
n=71 Participants
Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
|
|---|---|
|
Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL
|
37 Participants
|
SECONDARY outcome
Timeframe: Weeks 17 to 23Population: All participants who received cinacalcet
The number of participants who achieved a mean serum calcium x phosphorus (Ca x P) value \< 4.44 mmol\^2/L\^2 (55 mg\^2/dL\^2) during the effectiveness assessment phase. The calcium - phosphorus product is a derived value calculated from serum calcium and phosphorus levels.
Outcome measures
| Measure |
Cinacalcet
n=71 Participants
Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
|
|---|---|
|
Number of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol^2/L^2 (55 mg^2/dL^2)
|
56 Participants
|
SECONDARY outcome
Timeframe: Weeks 17 to 23Population: All participants who received cinacalcet
The number of participants who achieved a mean corrected serum calcium (Ca) value ≥ 2.1 and ≤ 2.37 mmol/L (8.4 to 9.5 mg/dL) during the effectiveness assessment phase.
Outcome measures
| Measure |
Cinacalcet
n=71 Participants
Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
|
|---|---|
|
Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L
|
39 Participants
|
SECONDARY outcome
Timeframe: Weeks 17 to 23Population: All participants who received cinacalcet
The number of participants who achieved a mean serum phosphorus value ≥ 1.13 and ≤ 1.78 mmol/L (3.5 to 5.5 mg/dL) during the effectiveness assessment phase.
Outcome measures
| Measure |
Cinacalcet
n=71 Participants
Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
|
|---|---|
|
Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L
|
38 Participants
|
SECONDARY outcome
Timeframe: Weeks 17 to 23Population: All participants who received cinacalcet
The number of participants who achieved a mean C-reactive protein (CRP) level of \< 0.6 mg/dL during the effectiveness assessment phase.
Outcome measures
| Measure |
Cinacalcet
n=71 Participants
Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
|
|---|---|
|
Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL
|
33 Participants
|
Adverse Events
Cinacalcet
Serious events: 27 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cinacalcet
n=71 participants at risk
Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
|
|---|---|
|
Cardiac disorders
Acute Coronary Syndrome
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Bradycardia
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Peritonitis
|
7.0%
5/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Jaundice
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Appendicitis
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Arteriovenous Fistula Site Infection
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bacteraemia
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Cellulitis
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia
|
2.8%
2/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Ross River Virus Infection
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Sepsis
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Complication
|
2.8%
2/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Thrombosis
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Complications of Transplanted Kidney
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Thrombosis in Device
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Blood Test Abnormal
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Platelet Count Decreased
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
2/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal Colic
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal Failure Chronic
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
Arteriovenous Fistula Operation
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypertension
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Iliac Artery Stenosis
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Necrosis Ischaemic
|
1.4%
1/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Cinacalcet
n=71 participants at risk
Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
7.0%
5/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.7%
14/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
25.4%
18/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
19.7%
14/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chest Pain
|
7.0%
5/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
5.6%
4/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
4/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
7.0%
5/71 • 23 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
|
5.6%
4/71 • 23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Headache
|
7.0%
5/71 • 23 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 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