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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

Tracking Information
First Submitted Date  ICMJE March 6, 2014
First Posted Date  ICMJE March 7, 2014
Results First Submitted Date  ICMJE August 6, 2020
Results First Posted Date  ICMJE September 14, 2020
Last Update Posted Date September 14, 2020
Study Start Date  ICMJE March 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2020)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2014)
  • The number of patients reaching S-phosphate goal [ Time Frame: End of wash out (pre randomization value) to end of treatment (Day 29) ]
    Comparison of the effect of AZD1722 versus placebo on the number of patients reaching serum phosphate goal levels defined as < 5.5 mg/dl (1.78 mmol/L) during 4 weeks of treatment
  • 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
  • Change from pre wash out in S-phosphate levels [ Time Frame: Pre wash out to end of treatment (Day 29) ]
    Comparison of the effect of AZD1722 versus pre wash out phosphate-lowering treatment, by comparing serum phosphate levels during AZD1722 treatment to pre wash out levels
  • Safety and tolerability of AZD1722 [ Time Frame: End of wash out (pre randomization value) to end of treatment (Day 29) ]
    To evaluate the safety and tolerability of AZD1722 as assessed by adverse event recording, vital signs, 12-lead electrocardiogram, physical examination, and safety laboratory monitoring
  • Dose response relationship [ Time Frame: End of wash out (pre randomization value) to end of treatment (Day 29) ]
    To characterize the dose response relationship of AZD1722 on serum phosphate levels
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Finding Study to Treat High Phosphate Levels in the Blood.
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hyperphosphatemia
Intervention  ICMJE
  • Drug: AZD1722
    AZD1722, oral tablet
  • Drug: Placebo
    Placebo bid, double dummy technique
Study Arms  ICMJE
  • Experimental: 1 mg bid
    1 mg AZD1722 bid
    Intervention: Drug: AZD1722
  • Experimental: 3 mg bid
    3 mg AZD1722 bid
    Intervention: Drug: AZD1722
  • Experimental: 10 mg bid
    10 mg AZD1722 bid
    Intervention: Drug: AZD1722
  • Experimental: 30 mg bid
    30 mg AZD1722 bid
    Intervention: Drug: AZD1722
  • Experimental: 3 mg od
    3 mg AZD1722 od
    Intervention: Drug: AZD1722
  • Experimental: 30 mg od
    30 mg AZD1722 od
    Intervention: Drug: AZD1722
  • Placebo Comparator: Placebo
    Placebo (double dummy technique)
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2020)
162
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2014)
300
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland,   Slovakia,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02081534
Other Study ID Numbers  ICMJE D5613C00001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ardelyx
Study Sponsor  ICMJE Ardelyx
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Geoffrey A Block, MD Denver Nephrology PC, Denver, CO 80230
PRS Account Ardelyx
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP