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TerminatedNCT01277510Updated Jun 29, 2020Results posted

Pediatric Chronic Kidney Disease Safety and Efficacy

A Phase 3 interventional study of cinacalcet capsule and placebo in Chronic Kidney Disease, Hyperparathyroidism and Hyperparathyroidism, Secondary, sponsored by Amgen. Terminated at 51 sites in 10 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-06-29.

Sponsored by Amgen · Phase 3, Interventional, and Treatment

Why this study was terminated
Study was put on clinical hold on 30 Jan 2013 following a subject fatality. Study was never restarted and was closed.
Phase
Phase 3
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
6 Years to 17 Years
Sex
All
01

Study summary

The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet.

Read the detailed description

Secondary hyperparathyroidism (SHPT) is a condition that can develop early in patients with chronic kidney disease (CKD), usually gets worse over time, and is known to cause problems for patients on dialysis. Children on dialysis can have a wide range of bone and growth issues, and common treatments have a chance of making these things worse by increasing serum calcium and serum phosphorus. Cinacalcet has been shown to be effective in controlling parathyroid hormone (PTH), calcium and phosphorus in adults. The purpose of this study is to show that including cinacalcet in the treatment of SHPT will lower the levels of intact parathyroid hormone (iPTH) in a larger number of pediatric patients with CKD who are receiving dialysis, compared to a treatment regimen that does not include cinacalcet.

02

Conditions studied

  • Chronic Kidney Disease
  • Hyperparathyroidism
  • Hyperparathyroidism, Secondary
  • Kidney Disease
  • Secondary Hyperparathyroidism

Keywords

  • dialysis
  • sensipar
  • mimpara
  • hemodialysis
  • peritoneal dialysis
  • renal
  • parathyroid hormone
  • pediatric
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 43 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 6 to less than 18 years at screening
  • Diagnosed with CKD and SHPT receiving hemodialysis or peritoneal dialysis for ≥ 2 months before randomization
  • Dry weight ≥ 12.5 kg at screening
  • iPTH obtained from the central laboratory must be > 300 pg/mL (31.8 pmol/L)
  • Serum calcium (corrected) obtained from the central laboratory must be ≥ 8.8 mg/dL (2.2 mmol/L)
  • Serum phosphorus obtained from the central laboratory ≥ 4.0 mg/dL (1.3 mmol/L) for children 6 to less than 12 years old, or ≥ 3.5 mg/dL (1.1 mmol/L) for children 12 to less than 18 years old
  • Subjects already receiving vitamin D sterols (either calcitriol or a synthetic analog), a stable dose within the last 2 months prior to randomization
  • Subjects taking growth hormone, a stable dose defined as no change > than 20% in the last 2 months prior to randomization
  • Subjects on anti-convulsant medication must be on a stable dose for 3 months, and have a therapeutic blood level of the anti-convulsant at the time of randomization
  • Subjects must be on a dialysate calcium concentration of ≥ 2.5 mEq/L (1.25 mmol/L) for at least 2 months prior to randomization

Exclusion criteria

Exclusion Criteria:

  • Underwent parathyroidectomy in the last 6 months
  • Anticipated parathyroidectomy within 6 months after randomization
  • Received therapy with cinacalcet (sensipar/mimpara) within the last month
  • A new onset of seizure or worsening of a pre-existing seizure disorder within the last 3 months
  • Scheduled date for kidney transplant from a known living donor that makes completion of the study unlikely
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
43 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.

    Drug: placebo · Drug: Standard of Care

  • Experimental
    Cinacalcet

    Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks.

    Drug: cinacalcet capsule · Drug: Standard of Care

Interventions

  • Drugcinacalcet capsule

    Cinacalcet was prepared for oral administration as both capsules for sprinkling and film coated tablets for swallowing.

    Also known as: Sensipar, Mimpara

  • Drugplacebo

    Placebo tablets and capsules for sprinkling identical to active treatment.

  • DrugStandard of Care

    All participants, regardless of treatment assignment, will receive standard of care with vitamin D sterols (calcitriol and its analogs), as prescribed by the treating physician.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase

    The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase (EAP; Weeks 25 - 30). When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available post-baseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.

    Time frame: From Baseline to the Efficacy Assessment Phase, Weeks 25-30

Secondary outcomes

  1. Percentage of Participants Achieving Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During the Efficacy Assessment Phase

    The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.

    Time frame: From Baseline to the Efficacy Assessment Phase (EAP), Weeks 25-30

  2. Percent Change From Baseline in Mean Corrected Total Serum Calcium During the Efficacy Assessment Period

    Serum calcium was reported as a corrected value by the central laboratory based on calcium and albumin concentrations: Corrected total calcium (mg/dL) = measured total serum calcium (mg/dL) + 0.8 (4.0 - Serum albumin (g/dL)). The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used."

    Time frame: From Baseline to the Efficacy Assessment Phase, Weeks 25-30.

  3. Percent Change From Baseline in Mean Serum Phosphorus During the Efficacy Assessment Phase

    The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.

    Time frame: From Baseline to the Efficacy Assessment Phase, Weeks 25-30.

  4. Percent Change From Baseline in Mean Phosphorous Product (Ca x P) During the Efficacy Assessment Phase

    The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.

    Time frame: From Baseline to end of Efficacy Assessment Period, assessed up to 30 weeks

  5. Growth Velocity From Baseline to End of Double-blind Phase

    Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of double-blind phase visit was at Week 30 by design but the last assessment in the double-blind phase was used due to the early termination of the study.

    Time frame: From Baseline to end of Efficacy Assessment at Week 30

  6. Growth Velocity From End of Double-blind Phase to End of Open-label Phase

    Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of open-label phase visit was at Week 60 by design but the last assessment in the open-label phase was used due to the early termination of the study.

    Time frame: End of double-blind phase (Week 30) until end of the open-label phase (Week 60)

  7. Percent Change From Baseline in Mean Ionized Calcium During the Efficacy Assessment Phase

    The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.

    Time frame: From Baseline to the Efficacy Assessment Phase, Weeks 25-30.

07

Results

Posted May 15, 2015
Limitations and caveats
The study was terminated early with a smaller sample size. However, the study was still sufficiently powered for the double-blind phase. The data collected in the open-label phase is very sparse.

Participant flow

The first patient was enrolled on 28 June 2011 and the last patient enrolled was on 15 January 2013. Eligible participants were between the ages of 6 to less than 18 years old who had chronic kidney (CKD) and secondary hyperparathyroidism treated with either hemodialysis or peritoneal dialysis for ≥ 2 months.

Double-blind Phase
Participant flow — Double-blind Phase
MilestonePlaceboCinacalcet
Started2122
Received investigational product2122
Completed84
Not completed1318
Withdrew: Non-compliance01
Withdrew: Adverse event10
Withdrew: Withdrawal by subject20
Withdrew: Administrative decision79
Withdrew: Death01
Withdrew: Protocol-specified criteria26
Withdrew: Other11
Open-label Phase
Participant flow — Open-label Phase
MilestonePlaceboCinacalcet
Started84
Received investigational product64
Completed11
Not completed73
Withdrew: Administrative decision43
Withdrew: Protocol-specified criteria10
Withdrew: Never received investigational product20

Outcome measures

PrimaryPercentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase

The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase (EAP; Weeks 25 - 30). When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available post-baseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.

Time frame:
From Baseline to the Efficacy Assessment Phase, Weeks 25-30
Reported as:
Number · percentage of participants
Percentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase
percentage of participantsPlaceboCinacalcet
Percentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase19.054.5
Statistical analysis
  • Placebo vs Cinacalcet · Cochran-Mantel-Haenszel · p = 0.017 · Difference (cinacalcet - placebo): 35.50 · 95% CI 8.76 to 62.24Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -\<12 years old or 12 - \<18 years old).
SecondaryPercentage of Participants Achieving Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During the Efficacy Assessment Phase

The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.

Time frame:
From Baseline to the Efficacy Assessment Phase (EAP), Weeks 25-30
Reported as:
Number · pecentage of participants
Percentage of Participants Achieving Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During the Efficacy Assessment Phase
pecentage of participantsPlaceboCinacalcet
Percentage of Participants Achieving Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During the Efficacy Assessment Phase23.827.3
Statistical analysis
  • Placebo vs Cinacalcet · Cochran-Mantel-Haenszel · p = 0.826 · Difference (cinacalcet - placebo): 3.46 · 95% CI -22.58 to 29.51Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -\<12 years old or 12 - \<18 years old).
SecondaryPercent Change From Baseline in Mean Corrected Total Serum Calcium During the Efficacy Assessment Period

Serum calcium was reported as a corrected value by the central laboratory based on calcium and albumin concentrations: Corrected total calcium (mg/dL) = measured total serum calcium (mg/dL) + 0.8 (4.0 - Serum albumin (g/dL)). The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used."

Time frame:
From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Mean Corrected Total Serum Calcium During the Efficacy Assessment Period
percent changePlaceboCinacalcet
Percent Change From Baseline in Mean Corrected Total Serum Calcium During the Efficacy Assessment Period-1.0 ± 1.91-4.6 ± 1.84
Statistical analysis
  • Placebo vs Cinacalcet · ANCOVA · p = 0.147 · Ls mean difference: -3.7 · 95% CI -8.6 to 1.3Cinacalcet-Placebo
SecondaryPercent Change From Baseline in Mean Serum Phosphorus During the Efficacy Assessment Phase

The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.

Time frame:
From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Mean Serum Phosphorus During the Efficacy Assessment Phase
percent changePlaceboCinacalcet
Percent Change From Baseline in Mean Serum Phosphorus During the Efficacy Assessment Phase10.2 (-0.8 to 21.2)4.9 (-5.5 to 15.3)
Statistical analysis
  • Placebo vs Cinacalcet · ANCOVA · p = 0.454 · Ls mean difference: -5.3 · 95% CI -19.4 to 8.9Cinacalcet-Placebo
SecondaryPercent Change From Baseline in Mean Phosphorous Product (Ca x P) During the Efficacy Assessment Phase

The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.

Time frame:
From Baseline to end of Efficacy Assessment Period, assessed up to 30 weeks
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Mean Phosphorous Product (Ca x P) During the Efficacy Assessment Phase
percent changePlaceboCinacalcet
Percent Change From Baseline in Mean Phosphorous Product (Ca x P) During the Efficacy Assessment Phase8.0 (-1.8 to 17.7)-2.0 (-11.4 to 7.4)
Statistical analysis
  • Placebo vs Cinacalcet · ANCOVA · p = 0.117 · Ls mean difference: -10.0 · 95% CI -22.5 to 2.6Cinacalcet-Placebo
SecondaryGrowth Velocity From Baseline to End of Double-blind Phase

Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of double-blind phase visit was at Week 30 by design but the last assessment in the double-blind phase was used due to the early termination of the study.

Time frame:
From Baseline to end of Efficacy Assessment at Week 30
Reported as:
Least squares mean · cm/year
Growth Velocity From Baseline to End of Double-blind Phase
cm/yearPlaceboCinacalcet
Growth Velocity From Baseline to End of Double-blind Phase3.1 (0.7 to 5.6)3.3 (0.8 to 5.8)
Statistical analysis
  • Placebo vs Cinacalcet · ANCOVA · p = 0.896 (No adjustments for multiplicity were made.) · Ls mean difference: 0.2 · 95% CI -3.1 to 3.6Cinacalcet-Placebo
SecondaryGrowth Velocity From End of Double-blind Phase to End of Open-label Phase

Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of open-label phase visit was at Week 60 by design but the last assessment in the open-label phase was used due to the early termination of the study.

Time frame:
End of double-blind phase (Week 30) until end of the open-label phase (Week 60)
Reported as:
Mean · cm/year
Growth Velocity From End of Double-blind Phase to End of Open-label Phase
cm/yearPlaceboCinacalcet
Growth Velocity From End of Double-blind Phase to End of Open-label Phase2.75 ± 3.231.21 ± 1.31
SecondaryPercent Change From Baseline in Mean Ionized Calcium During the Efficacy Assessment Phase

The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.

Time frame:
From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Mean Ionized Calcium During the Efficacy Assessment Phase
percent changePlaceboCinacalcet
Percent Change From Baseline in Mean Ionized Calcium During the Efficacy Assessment Phase-1.5 (-8.6 to 5.6)-2.3 (-8.2 to 3.5)
Statistical analysis
  • Placebo vs Cinacalcet · ANCOVA · p = 0.854 · Ls mean difference: -0.8 · 95% CI -9.4 to 7.9Cinacalcet-Placebo

Adverse events

Collected over 60 Weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Double-blind Phase: Placebo—9/21 (42.9%)17/21 (81%)
Double-blind Phase: Cinacalcet—9/22 (40.9%)16/22 (72.7%)
Open-label Phase: Previous Placebo—3/6 (50%)6/6 (100%)
Open-label Phase: Previous Cinacalcet—1/4 (25%)3/4 (75%)
Most frequent serious events
Showing 10 of 50
Most frequent serious events
EventDouble-blind Phase: PlaceboDouble-blind Phase: CinacalcetOpen-label Phase: Previous PlaceboOpen-label Phase: Previous Cinacalcet
PeritonitisInfections and infestations0/211/220/61/4
PneumoniaInfections and infestations0/210/220/61/4
Varices oesophagealGastrointestinal disorders0/210/221/60/4
Urinary tract infectionInfections and infestations1/210/221/60/4
Haemoglobin increasedInvestigations0/210/221/60/4
HypocalcaemiaMetabolism and nutrition disorders0/211/221/60/4
Hypertensive encephalopathyNervous system disorders1/210/221/60/4
HypertensionVascular disorders1/212/221/60/4
DiarrhoeaGastrointestinal disorders2/210/220/60/4
PyrexiaGeneral disorders2/210/220/60/4
Most frequent other events
Showing 10 of 113
Most frequent other events
EventDouble-blind Phase: PlaceboDouble-blind Phase: CinacalcetOpen-label Phase: Previous PlaceboOpen-label Phase: Previous Cinacalcet
Abdominal painGastrointestinal disorders2/213/222/60/4
NauseaGastrointestinal disorders2/214/222/61/4
PyrexiaGeneral disorders2/211/222/60/4
HypocalcaemiaMetabolism and nutrition disorders4/215/222/61/4
VomitingGastrointestinal disorders5/217/221/60/4
Catheter site related reactionGeneral disorders0/210/220/61/4
Chest painGeneral disorders0/210/220/61/4
Face oedemaGeneral disorders0/210/220/61/4
PainGeneral disorders1/210/220/61/4
NasopharyngitisInfections and infestations1/212/220/61/4

Baseline characteristics

Age, Continuous
Age, Continuous(years)PlaceboCinacalcetTotal
Mean13.2 ± 2.913.3 ± 3.613.2 ± 3.3
Age, Customized
Age, Customized(participants)PlaceboCinacalcetTotal
6 to < 12 years5611
12 to < 18 years161632
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboCinacalcetTotal
Female101222
Male111021
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)PlaceboCinacalcetTotal
White151631
Black or African American6511
Other011
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)PlaceboCinacalcetTotal
Hispanic or Latino538
Not Hispanic or Latino161935
Intact Parathyroid Hormone (iPTH)
Intact Parathyroid Hormone (iPTH)(pg/mL)PlaceboCinacalcetTotal
Mean795.8 ± 537.9757.1 ± 440.1776.0 ± 484.8
Corrected Total Serum Calcium
Corrected Total Serum Calcium(mg/dL)PlaceboCinacalcetTotal
Mean9.88 ± 0.629.91 ± 0.549.90 ± 0.58
Serum Phosphorous
Serum Phosphorous(mg/dL)PlaceboCinacalcetTotal
Mean6.37 ± 1.486.68 ± 1.786.53 ± 1.63
08

Study locations

51 sites
  • Research Site
    Birmingham, Alabama 35233, United States
  • Research Site
    Los Angeles, California 90095, United States
  • Research Site
    San Francisco, California 94143, United States
  • Research Site
    Gainesville, Florida 32610, United States
  • Research Site
    Baltimore, Maryland 21287, United States
  • Research Site
    Boston, Massachusetts 02115, United States
  • Research Site
    Kansas City, Missouri 64108, United States
  • Research Site
    Saint Louis, Missouri 63104, United States
  • Research Site
    Saint Louis, Missouri 63110, United States
  • Research Site
    Livingston, New Jersey 07039, United States
  • Research Site
    Bronx, New York 10467, United States
  • Research Site
    Greenville, North Carolina 27834, United States
  • Research Site
    Cincinnati, Ohio 45229, United States
  • Research Site
    Portland, Oregon 97227, United States
  • Research Site
    Philadelphia, Pennsylvania 19104, United States
  • Research Site
    Houston, Texas 77030, United States
  • Research Site
    San Antonio, Texas 78229, United States
  • Research Site
    Charlottesville, Virginia 22908, United States
  • Research Site
    Randwick, New South Wales 2031, Australia
  • Research Site
    Westmead, New South Wales 2145, Australia
  • Research Site
    Herston, Queensland 4029, Australia
  • Research Site
    Parkville, Victoria 3052, Australia
  • Research Site
    Bruxelles, 1020, Belgium
  • Research Site
    Edegem, 2650, Belgium
  • Research Site
    Gent, 9000, Belgium
  • Research Site
    Leuven, 3000, Belgium
  • Research Site
    Heidelberg, 69120, Germany
  • Research Site
    Marburg, 35043, Germany
  • Research Site
    Budapest, 1083, Hungary
  • Research Site
    Debrecen, 4032, Hungary
  • Research Site
    Pecs, 7623, Hungary
  • Research Site
    Szeged, 6720, Hungary
  • Research Site
    Mexico, Distrito Federal 04530, Mexico
  • Research Site
    Aguascalientes, 20219, Mexico
  • Research Site
    Gdansk, 80-952, Poland
  • Research Site
    Gorzow Wielkopolski, 66-400, Poland
  • Research Site
    Lodz, 93-338, Poland
  • Research Site
    Warszawa, 00-576, Poland
  • Research Site
    Warszawa, 04-730, Poland
  • Research Site
    Moscow, 107014, Russian Federation
  • Research Site
    Saint Petersburg, 198205, Russian Federation
  • Research Site
    Samara, 443095, Russian Federation
  • Research Site
    Banska Bystrica, 974 09, Slovakia
  • Research Site
    Bratislava, 833 40, Slovakia
  • Research Site
    Kosice, 040 11, Slovakia
  • Research Site
    Barcelona, Cataluña 08035, Spain
  • Research Site
    Barcelona, Cataluña 08035, Spain
  • Research Site
    Valencia, Comunidad Valenciana 46026, Spain
  • Research Site
    Baracaldo, PaÃ-s Vasco 48903, Spain
  • Research Site
    Baracaldo, País Vasco 48903, Spain
  • Research Site
    Madrid, 28046, Spain
09

References and documents

Publications

  • Warady BA, Iles JN, Ariceta G, Dehmel B, Hidalgo G, Jiang X, Laskin B, Shahinfar S, Vande Walle J, Schaefer F. A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of cinacalcet in pediatric patients with chronic kidney disease and secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2019 Mar;34(3):475-486. doi: 10.1007/s00467-018-4116-y. Epub 2018 Nov 30. PubMed 30506144 ↗
  • Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4. PubMed 32367309 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01277510
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Jan 17, 2011
Start date
Jun 28, 2011
Primary completion
Apr 30, 2014
Results posted
May 15, 2015
Last update
Jun 29, 2020

Study contacts

MD
study director · Amgen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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