CompletedPhase 2

12-month Study of AMG 073 in Renal Osteodystrophy

45 participantsStarted 2001-10

Plain-language summary

4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In addition, a bone biopsy will be performed at screening and at the end of study.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years of age of greater * Using effective contraceptive measures * iPTH greater than or equal to 300 pg/mL * Serum Calcium greater than or equal to 8.4 mg/dL; Hemoglobin greater than 9 * Stable hemodialysis for 1 month prior to day 1 Exclusion Criteria: * Any unstable medical condition * Pregnant or nursing women Recent parathyroidectomy * Change in Vitamin D therapy * Recent MI, Seizure, Malignancy, GI Disorder * Inability to swallow tablets

What they're measuring

To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry

Timeframe: entire study

Trial details

NCT IDNCT00527085

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2003-08

View on ClinicalTrials.gov More Renal Osteodystrophy trials