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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02151643
Recruitment Status : Completed
First Posted : May 30, 2014
Results First Posted : January 16, 2018
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
Clinipace Worldwide
Information provided by (Responsible Party):
Phosphate Therapeutics

Brief Summary:
The main purpose of this study is to see whether PT20 can help people with a high level of phosphate in their blood (called Hyperphosphatemia) that are being treated with dialysis for kidney disease.

Condition or disease Intervention/treatment Phase
Hyperphosphataemia Drug: PT20 Drug: Placebo Phase 2

Detailed Description:

PT20 represents a mechanism to address many of the limitations associated with current phosphate binding agents. The available clinical and non clinical evidence suggests that PT20 binds phosphate and prevents its uptake more efficiently than other phosphate binding drugs and may therefore either reduce the pill burden associated with controlling phosphate levels, or result in lower phosphate levels with the same pill burden.

The this study is the first to investigate the efficacy and safety of PT20 in subjects with dialysis-dependent chronic kidney disease (CKD).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease
Actual Study Start Date : May 7, 2014
Actual Primary Completion Date : March 18, 2015
Actual Study Completion Date : March 18, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 - PT20 400 mg tid

PT20 400 mg tid (1.2 g/day) administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study

Drug: PT20
Modified ferric oxide adipate tablets
Other Names:
  • Iron (III) oxide adipate
  • ferric oxide adipate
  • iron (III) oxide hydroxide adipate
  • M10L78

Experimental: Group 2 - PT20 800 mg tid

PT20 800 mg tid (2.4 g/day) administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study

Drug: PT20
Modified ferric oxide adipate tablets
Other Names:
  • Iron (III) oxide adipate
  • ferric oxide adipate
  • iron (III) oxide hydroxide adipate
  • M10L78

Experimental: Group 3 - PT20 1600 mg tid

PT20 1600 mg tid (4.8 g/day) administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study

Drug: PT20
Modified ferric oxide adipate tablets
Other Names:
  • Iron (III) oxide adipate
  • ferric oxide adipate
  • iron (III) oxide hydroxide adipate
  • M10L78

Experimental: Group 4 - PT20 3200 mg tid

PT20 3200 mg tid (9.6 g/day) administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study

Drug: PT20
Modified ferric oxide adipate tablets
Other Names:
  • Iron (III) oxide adipate
  • ferric oxide adipate
  • iron (III) oxide hydroxide adipate
  • M10L78

Placebo Comparator: Group 5 - Placebo tid

Matched Placebo (for PT20) tid administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study

Drug: Placebo
Placebo tablets matched to each PT20 dose arm
Other Name: Matched Placebo for PT20




Primary Outcome Measures :
  1. Change in Serum Phosphate Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) [ Time Frame: Day 1 to Day 29 ]
    The primary efficacy endpoint was the change in serum phosphate concentration from Baseline (Visit 7, Day 1) to Visit 11 (Day 29). All study specific blood samples were collected, processed and analysed using a central laboratory.


Secondary Outcome Measures :
  1. Change in Haemoglobin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) [ Time Frame: Day 1 to Day 29 ]
    Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in haemoglobin concentration. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Visit 11 (Day 29), which were to include the fixed, categorical effects of treatment as well as the continuous, fixed covariates of Baseline concentrations for haemoglobin. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis.

  2. Change in Serum Ferritin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) [ Time Frame: Day 1 to Day 29 ]
    Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in serum ferritin concentration. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Visit 11 (Day 29), which were to include the fixed, categorical effects of treatment and week (Visit), as well as the continuous, fixed covariates of Baseline concentrations for serum ferritin. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis.

  3. Change in Transferrin Saturation From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) [ Time Frame: Day 1 to Day 29 ]
    Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in transferrin saturation. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Day 29 (Visit 11), which were to include the fixed, categorical effects of treatment and week, as well as the continuous, fixed covariates of Baseline concentrations for transferrin saturation. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis.

  4. Change in Calcium x Phosphate Product From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) [ Time Frame: Day 1 to Day 29 ]
    Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in Calcium x Phosphate Product . An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Day 29 (Visit 11), which were to include the fixed, categorical effects of treatment, as well as the continuous, fixed covariates of Baseline concentrations for Calcium x Phosphate Product. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. In CKD subjects (Stages 3-5), the clinical recommendation (KDOQI) is that serum calcium x phosphate product should be maintained at < 55 mg^2/dL^2 (4.4 mmol^2 /L^2).

  5. Change in Gastrointestinal Symptom Rating System (GSRS) Overall Score From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) [ Time Frame: Day 1 to Day 29 ]
    The GSRS assesses the impact of treatment-related GI complications. It includes 15 items divided into 5 subscales (diarrhoea, indigestion, abdominal pain, constipation, and reflux), and uses a seven-grade Likert scale to assess symptoms (1 = no discomfort at all, 7 = very severe discomfort). The total score was calculated as the average score of all 15 items. If data were missing from one or more subscales, the mean of the completed items within the subscale was to be used for the subscale score, provided that more than half of the subscale items were complete. If more than half of the items within a subscale were missing, the subscale score and overall score were also to be defined as missing. The change in overall GSRS score from Baseline (Visit 7, Day 1) to Visit 11 (Day 29) was summarised by treatment and a two-sample t-test was to be used to identify differences between the placebo and PT20 dose groups. The higher the score, the more severe the gastrointestinal symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02151643


Sponsors and Collaborators
Phosphate Therapeutics
Clinipace Worldwide
Investigators
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Principal Investigator: Geoff Block, MD Denver Nephrologist
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Phosphate Therapeutics
ClinicalTrials.gov Identifier: NCT02151643    
Other Study ID Numbers: PT20-201
First Posted: May 30, 2014    Key Record Dates
Results First Posted: January 16, 2018
Last Update Posted: January 16, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Phosphate Therapeutics:
Dialysis Dependent Chronic Kidney Disease
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Physiological Effects of Drugs