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

NCT ID: NCT02151643

Last Updated: 2018-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-07
• Study Completion Date: 2015-03-18

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.

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).

Conditions

Hyperphosphataemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

PT20

Intervention Type: DRUG

Modified ferric oxide adipate tablets

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

Group Type: EXPERIMENTAL

PT20

Intervention Type: DRUG

Modified ferric oxide adipate tablets

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

Group Type: EXPERIMENTAL

PT20

Intervention Type: DRUG

Modified ferric oxide adipate tablets

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

Group Type: EXPERIMENTAL

PT20

Intervention Type: DRUG

Modified ferric oxide adipate tablets

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets matched to each PT20 dose arm

Interventions

PT20

Modified ferric oxide adipate tablets

Intervention Type: DRUG

Placebo

Placebo tablets matched to each PT20 dose arm

Intervention Type: DRUG

Other Intervention Names

Iron (III) oxide adipate; ferric oxide adipate; iron (III) oxide hydroxide adipate; M10L78; Matched Placebo for PT20

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinipace Worldwide

INDUSTRY

Sponsor Role: collaborator

Phosphate Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geoff Block, MD

Role: PRINCIPAL_INVESTIGATOR

Denver Nephrologist

References

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.

Reference Type: DERIVED

PMID: 40576086 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32651955 (View on PubMed)

Other Identifiers

PT20-201

Identifier Type: -

Identifier Source: org_study_id