Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 90
Updated:12/15/2017
Start Date:May 2014
End Date:March 2015

Use our guide to learn which trials are right for you!

The main purpose of this study is to see whether PT-20 can help people with a high level of
phosphate in their blood (called Hyperphosphatemia) that are being treated with dialysis for
kidney disease.

Elevated serum phosphate is a ubiquitous complication of reduced kidney function and evidence
suggests that this metabolic disturbance is associated with cardiovascular morbidity and
mortality in subjects receiving haemodialysis Efforts to achieve normal serum phosphate with
dietary restrictions, thrice weekly dialysis and phosphate binders have failed to
substantially improve the achieved serum phosphate levels. Data from a large international
practice pattern study suggest that approximately 50% of all dialysis subjects have serum
phosphate above the recommended target value of 5.5 mg/dL The standard of care for phosphate
control remains the prescription of phosphate binders with meals. These drugs act in the
small intestine to bind phosphate and prevent its absorption into the bloodstream. The 2
general categories of phosphate binders currently commercially available include calcium
containing phosphate binders (calcium carbonate and calcium acetate) and the non calcium
containing phosphate binders (sevelamer carbonate and lanthanum carbonate While these 2
classes of phosphate binders have similar efficacy, they differ substantially in their
associated side effects.

Inclusion Criteria:

- Men or women aged 18 90 years

- Subject must have a stable dialysis prescription for at least 28 days prior to start
of Screening.

- Subject must have the most recent serum phosphate measurement, taken during the 28
days prior to the start of Screening, of ≥ 4.0 mg/dL and ≤ 8 mg/dL.

Exclusion Criteria:

- Subject's most recent historical pre-dialysis serum bicarbonate value within 14 days
prior to the start of Screening (Visit 1) is < 18 mg/dL.

- Subject has, in the opinion of the investigator, severe chronic lung disease and/or
carbon dioxide retention.
We found this trial at
18
sites
1601
mi
from 02139
Houston, TX
Click here to add this to my saved trials
Arlington, Texas
1563
mi
from 02139
Arlington, TX
Click here to add this to my saved trials
Bakersfield, California
2587
mi
from 02139
Bakersfield, CA
Click here to add this to my saved trials
391
mi
from 02139
Bethesda, MD
Click here to add this to my saved trials
Denver, Colorado 80230
1763
mi
from 02139
Denver, CO
Click here to add this to my saved trials
847
mi
from 02139
Evanston, IL
Click here to add this to my saved trials
Fitchburg, Wisconsin
929
mi
from 02139
Fitchburg, WI
Click here to add this to my saved trials
Houston, Texas 77099
1601
mi
from 02139
Houston, TX
Click here to add this to my saved trials
Lauderdale Lakes, Florida 33311
1233
mi
from 02139
Lauderdale Lakes, FL
Click here to add this to my saved trials
Long Beach, California
2594
mi
from 02139
Long Beach, CA
Click here to add this to my saved trials
Nashville, Tennessee 37205
939
mi
from 02139
Nashville, TN
Click here to add this to my saved trials
Ontario, California
2557
mi
from 02139
Ontario, CA
Click here to add this to my saved trials
1763
mi
from 02139
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas
1763
mi
from 02139
San Antonio, TX
Click here to add this to my saved trials
Shreveport, Louisiana 71101
1410
mi
from 02139
Shreveport, LA
Click here to add this to my saved trials
Simi Valley, California 93065
2608
mi
from 02139
Simi Valley, CA
Click here to add this to my saved trials
2286
mi
from 02139
Tempe, AZ
Click here to add this to my saved trials
Whittier, California 90603
2579
mi
from 02139
Whittier, CA
Click here to add this to my saved trials