NCT00135304

Brief Summary

The purpose of this study is to compare the proportion of chronic kidney disease (CKD) subjects on dialysis receiving Sensipar® and low dose vitamin D or escalating doses of vitamin D alone who are able to achieve the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI) secondary hyperparathyroidism (HPT) treatment targets for both biointact parathyroid hormone (biPTH) and calcium-phosphorus (Ca x P) product.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

February 11, 2014

Status Verified

February 1, 2014

Enrollment Period

1.2 years

First QC Date

August 24, 2005

Last Update Submit

February 7, 2014

Conditions

Secondary Hyperparathyroidism

Keywords

Vitamin DSensipar®Cinacalcet HClChronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Achieving the NKF-K/DOQI targets for both biPTH (80-160 pg/mL, equivalent to iPTH 150-300 pg/mL) and Ca x P (less than 55 mg^2/dL^2) during the assessment phase

    Proportion of subjects in each treatment group simultaneously achieving the National Kidney Foundation - Kidney Disease Outcome Quality Initiative (NKF-K/DOQI) targets for both biPTH (80-160 pg/mL, equivalent to iPTH 150-300 pg/mL) and Ca x P (\< 55 mg\^2/dL\^2) during the assessment phase (last 11 weeks of study following a 16-week titration phase)

    Weeks 17 - 27

Secondary Outcomes (13)

  • Absolute Change from Baseline for P During the Assessment Phase

    Baseline to weeks 17-27

  • Proportion of Participants with ≥ 30% Reduction from Baseline in Mean iPTH During the Assessment Phase

    Baseline and Weeks 17-27

  • Percent Change from Baseline for Calcium During the Assessment Phase

    Baseline to weeks 17-27

  • Percent Change from Baseline for Phosphorus During the Assessment Phase

    Baseline to weeks 17-27

  • Percent Change from Baseline for Ca x P During the Assessment Phase

    Baseline to weeks 17-27

  • +8 more secondary outcomes

Study Arms (2)

Cinacalcet and low-dose Vitamin D

EXPERIMENTAL

Cinacalcet and low-dose IV Vitamin D

Drug: Sensipar®Drug: Vitamin D

Vitamin D alone

ACTIVE COMPARATOR

Escalating doses of IV Vitamin D alone

Drug: Vitamin D

Interventions

Sensipar®DRUG

Cinacalcet hydrochloride

Also known as: Cinacalcet hydrochloride, Cinacalcet HCL, Cinacalcet
Cinacalcet and low-dose Vitamin D
Vitamin DDRUG

Vitamin D administered IV

Also known as: paricalcitol, doxercalciferol
Cinacalcet and low-dose Vitamin DVitamin D alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Fishbane S, Shapiro WB, Corry DB, Vicks SL, Roppolo M, Rappaport K, Ling X, Goodman WG, Turner S, Charytan C. Cinacalcet HCl and concurrent low-dose vitamin D improves treatment of secondary hyperparathyroidism in dialysis patients compared with vitamin D alone: the ACHIEVE study results. Clin J Am Soc Nephrol. 2008 Nov;3(6):1718-25. doi: 10.2215/CJN.01040308.

    PMID: 18945995BACKGROUND

  • Shireman TI, Almehmi A, Wetmore JB, Lu J, Pregenzer M, Quarles LD. Economic analysis of cinacalcet in combination with low-dose vitamin D versus flexible-dose vitamin D in treating secondary hyperparathyroidism in hemodialysis patients. Am J Kidney Dis. 2010 Dec;56(6):1108-16. doi: 10.1053/j.ajkd.2010.07.012. Epub 2010 Oct 15.

    PMID: 20951487BACKGROUND

  • TBD.Sensipar plus low dose vitamin D (ACHIEVE).Journal-004521;

    BACKGROUND

  • TBD.Time in target.Journal-004521;

    BACKGROUND

Related Links

MeSH Terms

Conditions

Hyperparathyroidism, SecondaryRenal Insufficiency, Chronic

Interventions

CinacalcetVitamin Dparicalcitol1 alpha-hydroxyergocalciferol

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsSecosteroidsSteroidsFused-Ring Compounds

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 26, 2005

Study Start

August 1, 2005

Primary Completion

October 1, 2006

Study Completion

December 1, 2006

Last Updated

February 11, 2014

Record last verified: 2014-02