At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 552 enrolled

Drug / intervention

cinacalcet +1 moredrug

Likely dose

Cinacalcet 30–180 mg once daily (starting dose 30 mg/day)AI-extracted

Key inclusion· 3

✓ESRD patients requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month
✓Mean of 2 iPTH determinations within 21 days before randomization (at least 2 days apart) ≥300 and <800 pg/mL; if biPTH, mean ≥150 and <410 pg/mL
✓Mean of 2 serum calcium determinations (corrected for albumin) ≥8.4 mg/dL on the same days as PTH determinations

Key exclusion· 7

✕Unstable medical condition, including hospitalization within 30 days (except for dialysis vascular access revision), or otherwise unstable per investigator judgment
✕Parathyroidectomy within 6 months before day 1
✕Vitamin D therapy for <21 days before day 1, or brand/dose change within 21 days before day 1; if not on vitamin D, must remain free of it for 21 days before day 1
✕Use of CYP2D6-metabolized medications with narrow therapeutic index (e.g., flecainide, vinblastine, thioridazine, most tricyclic antidepressants) within 21 days before day 1; amitriptyline permitted

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00110890

NCT00110890Phase 4Completed

Compare CT.gov

An Open-Label, Randomised Study Using Cinacalcet to Improve Achievement of Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With ESRD

Amgen·interventional·Posted May 17, 2005·Updated Mar 7, 2011

In Brief

A Phase 4 clinical trial evaluating cinacalcet and Standard of care for End Stage Renal Disease. Completed, enrolled 552 participants.

Detailed Summary

The purpose of this study is to evaluate the ability of a treatment strategy, that includes cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid hormone (PTH) compared with the standard of care.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsEnd Stage Renal Disease

Countries--

Collaborators--

Timeline

Phase 4CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMay 2004

Primary CompletionApr 2005

First PostedMay 2005

Study CompletionSep 2007

TodayJul 2026

First PostedMay 17, 2005

Enrollment StartMay 1, 2004

Primary CompletionApr 1, 2005

Study CompletionSep 1, 2007

TodayJul 2, 2026

Enrollment to primary: 11 monthsPosted 21.1 years ago

Interventions

cinacalcetdrug

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.

Standard of careother

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.