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

NCT02151643 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: PT20-201
• Study Type: interventional
• Target: 153
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperphosphataemia

Keywords

Dialysis Dependent Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Change in Serum Phosphate Concentration From Baseline (Visit 7, Day 1) to Visit 11 (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.

  Day 1 to Day 29

Secondary Outcomes (5)

• Change in Haemoglobin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)

  Day 1 to Day 29

• Change in Serum Ferritin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)

  Day 1 to Day 29

• Change in Transferrin Saturation From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)

  Day 1 to Day 29

• Change in Calcium x Phosphate Product From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)

  Day 1 to Day 29

• Change in Gastrointestinal Symptom Rating System (GSRS) Overall Score From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)

  Day 1 to Day 29

Study Arms (5)

Group 1 - PT20 400 mg tid

EXPERIMENTAL

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

Group 2 - PT20 800 mg tid

EXPERIMENTAL

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

Group 3 - PT20 1600 mg tid

EXPERIMENTAL

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

Group 4 - PT20 3200 mg tid

EXPERIMENTAL

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

Group 5 - Placebo tid

PLACEBO COMPARATOR

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

Interventions

PT20 DRUG

Modified ferric oxide adipate tablets

Also known as: Iron (III) oxide adipate, ferric oxide adipate, iron (III) oxide hydroxide adipate, M10L78

Group 1 - PT20 400 mg tid; Group 2 - PT20 800 mg tid; Group 3 - PT20 1600 mg tid; Group 4 - PT20 3200 mg tid

Placebo DRUG

Placebo tablets matched to each PT20 dose arm

Also known as: Matched Placebo for PT20

Group 5 - Placebo tid

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Phosphate Therapeutics: lead
• Clinipace Worldwide: collaborator

Related Publications (2)

• Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

  PMID: 40576086 DERIVED

• Sampson M, Faria N, Powell JJ; PEACH study investigators. Efficacy and safety of PT20, an iron-based phosphate binder, for the treatment of hyperphosphataemia: a randomized, double-blind, placebo-controlled, dose-ranging, Phase IIb study in patients with haemodialysis-dependent chronic kidney disease. Nephrol Dial Transplant. 2021 Jul 23;36(8):1399-1407. doi: 10.1093/ndt/gfaa116.

  PMID: 32651955 DERIVED

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

Iron

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Results Point of Contact

• Title: Mark Sampson
• Organization: Shield Therapeutics

msampson@shieldtx.com

+44 (0) 207 186 8500

Study Officials

• Geoff Block, MD

  Denver Nephrologist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: May 30, 2014
• Study Start: May 7, 2014
• Primary Completion: March 18, 2015
• Study Completion: March 18, 2015
• Last Updated: January 16, 2018
• Results First Posted: January 16, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share