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

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ClinicalTrials.gov Identifier: NCT02081534

Recruitment Status : Completed

First Posted : March 7, 2014

Results First Posted : September 14, 2020

Last Update Posted : September 14, 2020

Sponsor:

Information provided by (Responsible Party):

Ardelyx

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Hyperphosphatemia	Drug: AZD1722 Drug: Placebo	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	162 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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 Start Date :	March 2014
Actual Primary Completion Date :	November 2014
Actual Study Completion Date :	November 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 mg bid 1 mg AZD1722 bid	Drug: AZD1722 AZD1722, oral tablet
Experimental: 3 mg bid 3 mg AZD1722 bid	Drug: AZD1722 AZD1722, oral tablet
Experimental: 10 mg bid 10 mg AZD1722 bid	Drug: AZD1722 AZD1722, oral tablet
Experimental: 30 mg bid 30 mg AZD1722 bid	Drug: AZD1722 AZD1722, oral tablet
Experimental: 3 mg od 3 mg AZD1722 od	Drug: AZD1722 AZD1722, oral tablet
Experimental: 30 mg od 30 mg AZD1722 od	Drug: AZD1722 AZD1722, oral tablet
Placebo Comparator: Placebo Placebo (double dummy technique)	Drug: Placebo Placebo bid, double dummy technique

Outcome Measures

Primary Outcome Measures :

Change in Serum Phosphate Levels [ Time Frame: End of wash out (pre randomization value) to end of treatment (Day 29) ]
Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment

Secondary Outcome Measures :

Change From Baseline in Calcium x Phosphorus Product [ Time Frame: End of wash out (pre randomization value) to end of treatment (Day 29) ]
Change from baseline (end of wash out) in calcium x phosphorus product

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081534

Locations

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United States, California
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
United States, Colorado
Research Site
Denver, Colorado, United States
United States, Florida
Research Site
Pembroke Pines, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Winter Park, Florida, United States
United States, Massachusetts
Research Site
Springfield, Massachusetts, United States
United States, Michigan
Research Site
Detroit, Michigan, United States
United States, New Jersey
Research Site
Voorhees, New Jersey, United States
United States, New York
Research Site
Flushing, New York, United States
Research Site
Maspeth, New York, United States
United States, North Carolina
Research Site
Charlotte, North Carolina, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
United States, Texas
Research Site
San Antonio, Texas, United States
Poland
Research Site
Bialystok, Poland
Research Site
Czestochowa, Poland
Research Site
Dzialdowo, Poland
Research Site
Legnica, Poland
Research Site
Lublin, Poland
Research Site
Radom, Poland
Research Site
Szczecin, Poland
Research Site
Warszawa, Poland
Research Site
Wroclaw, Poland
Research Site
Zamosc, Poland
Research Site
Zary, Poland
Research Site
Zgierz, Poland
Slovakia
Research Site
Banska Bystrica, Slovakia
Research Site
Bratislava, Slovakia
Research Site
Hlohovec, Slovakia
Research Site
Kosice, Slovakia
Research Site
Piestany, Slovakia
Research Site
Puchov, Slovakia
Research Site
Senica, Slovakia
United Kingdom
Research Site
Birmingham, United Kingdom
Research Site
Doncaster, United Kingdom
Research Site
Exeter, United Kingdom
Research Site
Hull, United Kingdom
Research Site
Leicester, United Kingdom
Research Site
London, United Kingdom

Sponsors and Collaborators

Ardelyx

Investigators

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Principal Investigator:	Geoffrey A Block, MD	Denver Nephrology PC, Denver, CO 80230

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Ardelyx
ClinicalTrials.gov Identifier:	NCT02081534
Other Study ID Numbers:	D5613C00001
First Posted:	March 7, 2014 Key Record Dates
Results First Posted:	September 14, 2020
Last Update Posted:	September 14, 2020
Last Verified:	August 2020

Keywords provided by Ardelyx:


S-phosphate, hyperphosphatemia, hemodialysis, ESRD

Additional relevant MeSH terms:

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Hyperphosphatemia Phosphorus Metabolism Disorders Metabolic Diseases

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