Dose Finding Study to Treat High Phosphate Levels in the Blood.

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperphosphatemia

In brief

Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks treatment period

Key facts

Study ID

NCT02081534

Run by

Ardelyx

People needed

162

Starts

2014-03-01

Expected to finish

2014-11-01

Last updated by the study team

2020-09-14

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Females and males aged ≥18 years
• Chronic maintenance hemodialysis 3 x/week for a at least 3 months
• Prescribed and taking at least 3 doses of phosphate binder per day
• Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening
• Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening
• For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out

You may not qualify if…

• Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.
• Serum parathyroid hormone >1200 pg/mL
• Significant metabolic acidosis
• Clinical signs of hypovolemia at randomization

Where it is running

• Research Site — Downey, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Sacramento, California, United States
• Research Site — Whittier, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Pembroke Pines, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Winter Park, Florida, United States
• Research Site — Springfield, Massachusetts, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Voorhees Township, New Jersey, United States
• Research Site — Flushing, New York, United States
• Research Site — Maspeth, New York, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Bialystok, Poland
• Research Site — Częstochowa, Poland
• Research Site — Działdowo, Poland
• Research Site — Legnica, Poland
• Research Site — Lublin, Poland
• Research Site — Radom, Poland
• Research Site — Szczecin, Poland
• Research Site — Warsaw, Poland
• Research Site — Wroclaw, Poland

Full record on ClinicalTrials.gov

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