A Research Study for Patients With End-Stage Renal Diseas... | NCT00110890

NCT00110890

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of care	No Intervention	Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets.	Other: Standard of care
Cinacalcet	Other	Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on iPTH values.	Drug: cinacalcet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cinacalcet	Drug	Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg.	Cinacalcet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Mean PTH ≤ 300 pg/mL	Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase	Efficacy Assessment Phase (weeks 17 to 23)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL	Number of participants with mean calcium x phosphorus (Ca x P) < 55 mg^2/dL^2 and intact parathyroid hormone (iPTH) ≤ 300 pg/mL during the efficacy assessment phase	Efficacy Assesment Phase (weeks 17-23)
Number of Participants With Mean Ca x P < 55 mg^2/dL^2

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ESRD patients requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month
The mean of 2 iPTH determinations within 21 days before randomization and drawn at least 2 days apart must be greater than or equal to 300 pg/mL (31.8 pmol/L) and less than 800 pg/mL (84.8 pmol/L). If biPTH is determined, the mean levels must be greater than or equal to 150 pg/mL (15.9 pmol/L) and less than 410 pg/mL (43.5 pmol/L)
The mean of 2 serum calcium determinations (corrected for albumin) drawn on the same day as the PTH determinations must be greater than or equal to 8.4 mg/dL (2.1 mmol/L)

Exclusion Criteria:

Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator
Have had a parathyroidectomy in the 6 months before day 1
Have received vitamin D therapy for less than 21 days before day 1 or required a change in prescribed vitamin D brand or dose within 21 days before day 1. If subjects are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for the 21 days before day 1.
Received, within 21 days before day 1 of the dose titration phase, therapy with medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic index (e.g., flecainide, vinblastine, thioridazine, and most tricyclic antidepressants). The tricyclic antidepressant amitriptyline is permitted. - Experienced a myocardial infarction within 3 months prior to day 1
Are currently enrolled in, or have not yet completed at least 30 days before day 1, other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable)
Have a gastrointestinal disorder that may be associated with impaired absorption or orally administered medications or an inability to swallow tablets

Name	Affiliation	Role
MD	Amgen	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18178780	Result	Messa P, Macario F, Yaqoob M, Bouman K, Braun J, von Albertini B, Brink H, Maduell F, Graf H, Frazao JM, Bos WJ, Torregrosa V, Saha H, Reichel H, Wilkie M, Zani VJ, Molemans B, Carter D, Locatelli F. The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism. Clin J Am Soc Nephrol. 2008 Jan;3(1):36-45. doi: 10.2215/CJN.03591006.
19365139

Label	URL
AmgenTrials clinical trials website	View source

Arm/Group Information

ID	Title	Description
FG000	Cinacalcet	Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
FG001	Standard of Care	Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000368 subjects FG001184 subjects
End of Dose Optimization Phase		FG000316 subjectsWeeks 1 to 16 FG001170 subjectsWeeks 1 to 16
End of Efficacy Assessment Phase		FG000280 subjectsWeeks 17 to 23 FG001150 subjectsWeeks 17 to 23
COMPLETED		FG0007 subjectsFollow-up Phase FG0015 subjectsFollow-up Phase
NOT COMPLETED		FG000361 subjects FG001179 subjects

Type	Comment	Reasons
Adverse Event		FG00030 subjects FG0017 subjects
Death		FG00016 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Cinacalcet	Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
BG001	Standard of Care

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Mean PTH ≤ 300 pg/mL

Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase

Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)

Posted

Number

Participants

Efficacy Assessment Phase (weeks 17 to 23)

ID	Title	Description
OG000	Cinacalcet	Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
OG001	Standard of Care

Adverse Events Module

ID	Term
D007676	Kidney Failure, Chronic
D006962	Hyperparathyroidism, Secondary

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic