Clinical trial NCT02081534: Dose Finding Study to Treat High Phosphate Levels in the Blood.
Official title: A Phase 2b, Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicentre Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of AZD1722 to Treat Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperphosphatemia
Keywords: S-phosphate, hyperphosphatemia, hemodialysis, ESRD
Lead sponsor: Ardelyx
Sponsor class: INDUSTRY
First posted: 2014-03-07
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: The study consists of a screening period of approximately 1 week, a wash out period of up to 3 weeks, where existing phosphate lowering medication is withheld, a 4-week treatment period and a follow-up period of up to 2 weeks, during which patients are put back on their pre washout phosphate lowering medication.

The wash out period will be either 1 week, 2 weeks or 3 weeks depending on the increase in s-phosphate levels.

There are 7 parallel treatment arms in the study with bid and od treatment regimens.

Laboratory efficacy endpoints and safety assessments will be evaluated at various times throughout the study.

The target population of the study is: male or female patients, above18 years of age with End Stage Renal Disease (ESRD) on chronic maintenance hemodialysis (HD) 3 times a week for a minimum of 3 months.

Eligibility criteria: Inclusion Criteria:

1. Females and males aged ≥18 years
2. Chronic maintenance hemodialysis 3 x/week for a at least 3 months
3. Prescribed and taking at least 3 doses of phosphate binder per day
4. 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
5. Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening
6. 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

Exclusion Criteria:

1. 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.
2. Serum parathyroid hormone \>1200 pg/mL
3. Significant metabolic acidosis
4. Clinical signs of hypovolemia at randomization

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Primary outcomes:
measure: Change in Serum Phosphate Levels
timeFrame: End of wash out (pre randomization value) to end of treatment (Day 29)
Secondary outcomes:
measure: Change From Baseline in Calcium x Phosphorus Product
timeFrame: End of wash out (pre randomization value) to end of treatment (Day 29)
Other outcomes:
Locations:
city: Downey
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: Whittier
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Winter Park
country: United States
facility: Research Site
state: Florida
city: Springfield
country: United States
facility: Research Site
state: Massachusetts
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Voorhees
country: United States
facility: Research Site
state: New Jersey
city: Flushing
country: United States
facility: Research Site
state: New York
city: Maspeth
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Bialystok
country: Poland
facility: Research Site
city: Czestochowa
country: Poland
facility: Research Site
city: Dzialdowo
country: Poland
facility: Research Site
city: Legnica
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Radom
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Zamosc
country: Poland
facility: Research Site
city: Zary
country: Poland
facility: Research Site
city: Zgierz
country: Poland
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Hlohovec
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Piestany
country: Slovakia
facility: Research Site
city: Puchov
country: Slovakia
facility: Research Site
city: Senica
country: Slovakia
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Doncaster
country: United Kingdom
facility: Research Site
city: Exeter
country: United Kingdom
facility: Research Site
city: Hull
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Denver Nephrology PC, Denver, CO 80230
name: Geoffrey A Block, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Block GA, Rosenbaum DP, Yan A, Greasley PJ, Chertow GM, Wolf M. The effects of tenapanor on serum fibroblast growth factor 23 in patients receiving hemodialysis with hyperphosphatemia. Nephrol Dial Transplant. 2019 Feb 1;34(2):339-346. doi: 10.1093/ndt/gfy061.