CompletedPhase 2

A Phase 2 Study of Intravenous or Subcutaneous Dosing of Sotatercept (ACE-011) in Patients With End-Stage Kidney Disease on Hemodialysis

Belgium, Germany50 participantsStarted 2013-11-30

Plain-language summary

To determine the optimal route of administration, dose level, and safety of intravenous and subcutaneous dosing of sotatercept for maintaining hemoglobin levels in subjects who are on hemodialysis.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Males or females ≥ 18 years of age.
✓. Subjects on at least 6 hours of hemodialysis per week, for at least 12 weeks before screening
✓. Subjects must be on a stable intravenous or subcutaneous dose of Erythropoietin Stimulating Agents (excluding methoxy polyethylene glycol-epoetin beta \[Mircera\]) to maintain hemoglobin.
✓. A mean predialysis hemoglobin concentration ≥ 10 g/dL (grams per deciliter) to ≤ 12 g/dL (≥ 100 g/L (grams per liter) to ≤ 120 g/L) obtained from three consecutive days.

Exclusion criteria

✕. Non renal causes of anemia
✕. Subjects on peritoneal dialysis.
✕. Systemic hematological disease
✕. Uncontrolled diabetes mellitus (HbA1c (hemoglobin A1c) \> 9%) at screening.
✕. Uncontrolled hypertension defined as mean of home systolic blood pressure \> 160 mm Hg (millimeter of mercury) or mean of home diastolic blood pressure \> 90 mm Hg calculated once during the screening period prior to randomization
✕. Subjects with heart failure
✕. History of malignancy (except excised and cured non-melanoma skin cancer, or cervical carcinoma in situ that was surgically ablated more than 5 years ago).
✕. Anticipated or scheduled living donor renal transplant during the course of the study.

What they're measuring

Area Under the Serum Concentration-Time Curve Over Dosing Interval (AUC14d) (14 Days)

Timeframe: Doses 1-2: predose and postdose at 5 min (IV only) 4 hours, 3, and 7 days after each dose; Doses 3-7: predose, and postdose at 5 min after IV injection after each dose; Final dose: predose and postdose at 5 min (IV only) 4 hours, 3, 7, 14 days after dose

Area Under the Serum Concentration- Time Curve Over From Day 1 to Day 28 (AUC28d)

Maximum Observed Serum Concentration Obtained From the First Dose (Cmax14d)

Maximum Observed Serum Concentration (Cmax28d) Obtained From the Combined First 2 Doses

Time to Reach Maximum Observed Serum Concentration (Tmax)

Timeframe: Doses 1-2: pre- and postdose at 5 min (IV only) 4 hrs, 3, and 7 days after each dose; Doses 3-7: pre-, and postdose at 5 min after IV injection after each dose; Final dose: pre- and postdose at 5 min (IV only), 4 hrs, 3, 7, 14, 28, 56, 84, and 112 days

Trial details

NCT IDNCT01999582

SponsorCelgene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-08-31

Results submitted2024-01-04

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