HyperphosphataemiaPhase 2NCT02151643

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

A Phase 2 study testing PT20 in people with Hyperphosphataemia, run by Phosphate Therapeutics.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Hyperphosphataemia
What is being tested?: PT20
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 153 participants
Where: No sites listed yet
Study dates: 7 May 2014to 18 Mar 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

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.

Read the 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
Being tested: PT20, Placebo
Keywords: Dialysis Dependent Chronic Kidney Disease
Medical subject headings: Hyperphosphatemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PT20Drug
Also called Iron (III) oxide adipate, ferric oxide adipate, iron (III) oxide hydroxide adipate, M10L78
Modified ferric oxide adipate tablets
PlaceboDrug
Also called Matched Placebo for PT20
Placebo tablets matched to each PT20 dose arm

Study groups in NCT02151643
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1 to Day 29

Secondary outcomes (5)

Change in Haemoglobin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (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.
Measured: Day 1 to Day 29
Change in Serum Ferritin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (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.
Measured: Day 1 to Day 29
Change in Transferrin Saturation From Baseline (Visit 7, Day 1) to Visit 11 (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.
Measured: Day 1 to Day 29
Change in Calcium x Phosphate Product From Baseline (Visit 7, Day 1) to Visit 11 (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).
Measured: 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)
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.
Measured: Day 1 to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 May 201418 Mar 2015

First posted30 May 2014 (estimated)
Study start7 May 2014
Primary completion18 Mar 2015
Study completion18 Mar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HyperphosphataemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02151643
Sponsor's protocol ID: PT20-201
Status last verified: Dec 2017
First submitted: 28 May 2014
Last updated: 16 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40576086
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.
PubMed 32651955

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingObservational study
Tenapanor in Maintenance Hemodialysis Patients
Hyperphosphatemia, Maintenance Hemodialysis
Active, not recruitingPhase 3
A Clinical Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
Hyperphosphatemia Patients on Hemodialysis
RecruitingObservational study
Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule
Hyperphosphatemia
Recruiting
Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
Kidney Failure, Chronic, Hyperphosphatemia
RecruitingPhase 2
Phosphate in Acute Pancreatitis
Pancreatitis

All Hyperphosphataemia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease
ClinicalTrials.gov ID: NCT02151643
Acronym / sponsor ID: PT20-201
Conditions: Hyperphosphataemia
Keywords: Dialysis Dependent Chronic Kidney Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Phosphate TherapeuticsIndustry (pharma, biotech, devices)
Collaborators: Clinipace Worldwide
Study start: 7 May 2014 (actual)
Primary completion: 18 Mar 2015 (actual)
Study completion: 18 Mar 2015 (actual)
First posted: 30 May 2014 (estimated)
Results: Posted 16 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Group 1 - PT20 400 mg tid	Experimental	Drug: PT20PT20 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 2 - PT20 800 mg tid	Experimental	Drug: PT20PT20 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 3 - PT20 1600 mg tid	Experimental	Drug: PT20PT20 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 4 - PT20 3200 mg tid	Experimental	Drug: PT20PT20 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 5 - Placebo tid	Placebo comparator	Drug: PlaceboMatched 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

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PT20Also: Iron (III) oxide adipate, ferric oxide adipate, iron (III) oxide hydroxide adipate, M10L78Modified ferric oxide adipate tablets	Drug	Group 1 - PT20 400 mg tid, Group 2 - PT20 800 mg tid, Group 3 - PT20 1600 mg tid, Group 4 - PT20 3200 mg tid
PlaceboAlso: Matched Placebo for PT20Placebo tablets matched to each PT20 dose arm	Drug	Group 5 - Placebo tid

Primary outcome

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.

5 secondary outcomes

Change in Haemoglobin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
Time frame: Day 1 to Day 29
Change in Serum Ferritin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
Time frame: Day 1 to Day 29
Change in Transferrin Saturation From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
Time frame: Day 1 to Day 29
Change in Calcium x Phosphate Product From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
Time frame: 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)
Time frame: Day 1 to Day 29

Results and safety

Results posted to the registry on 16 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 - PT20 400 mg Tid	26	20
Group 2 - PT20 800 mg Tid	25	21
Group 3 - PT20 1600 mg Tid	25	21
Group 4 - PT20 3200 mg Tid	39	32
Group 5 - Placebo Tid	38	35

Primary outcome: Change in Serum Phosphate Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)

Time frame: Day 1 to Day 29. Mean (Full Range). Unit: mg/dL

Measure	Group 1 - PT20 400 mg Tid n = 20	Group 2 - PT20 800 mg Tid n = 20	Group 3 - PT20 1600 mg Tid n = 20	Group 4 - PT20 3200 mg Tid n = 32	Group 5 - Placebo Tid n = 35
Value	-0.4 (-3.1 to 3.5)	-0.59 (-4.9 to 2.6)	-1.29 (-4.6 to 1.5)	-1.363 (-5.2 to 4.6)	-0.165 (-2.5 to 2.4)

Group 1 - PT20 400 mg Tid vs Group 2 - PT20 800 mg Tid vs Group 3 - PT20 1600 mg Tid vs Group 4 - PT20 3200 mg Tid vs Group 5 - Placebo Tid: p = 0.784, F-test
Group 1 - PT20 400 mg Tid vs Group 2 - PT20 800 mg Tid vs Group 3 - PT20 1600 mg Tid vs Group 4 - PT20 3200 mg Tid vs Group 5 - Placebo Tid: p = 0.905, F-test
Group 1 - PT20 400 mg Tid vs Group 2 - PT20 800 mg Tid vs Group 3 - PT20 1600 mg Tid vs Group 4 - PT20 3200 mg Tid vs Group 5 - Placebo Tid: p = 0.976, F-test

Population analysed: Intent-to-Treat (ITT) population.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event.. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 - PT20 400 mg Tid	0 of 24 (0%)	10 of 24 (41.7%)	0 of 24
Group 2 - PT20 800 mg Tid	1 of 23 (4.3%)	11 of 23 (47.8%)	0 of 23
Group 3 - PT20 1600 mg Tid	1 of 22 (4.5%)	13 of 22 (59.1%)	0 of 22
Group 4 - PT20 3200 mg Tid	5 of 36 (13.9%)	16 of 36 (44.4%)	0 of 36
Group 5 - Placebo Tid	5 of 36 (13.9%)	16 of 36 (44.4%)	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40576086Natale 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.
Derived from this study: PubMed 32651955Sampson 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.
Individual participant dataSharing planned: No

Related trials for Hyperphosphataemia

Not yet recruitingObservational study
Tenapanor in Maintenance Hemodialysis Patients
Hyperphosphatemia, Maintenance Hemodialysis
Active, not recruitingPhase 3
A Clinical Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
Hyperphosphatemia Patients on Hemodialysis
RecruitingObservational study
Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule
Hyperphosphatemia
Recruiting
Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
Kidney Failure, Chronic, Hyperphosphatemia
RecruitingPhase 2
Phosphate in Acute Pancreatitis
Pancreatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Geoff Block, MD principal investigator

Denver Nephrologist

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PT20 in people with Hyperphosphataemia, run by Phosphate Therapeutics.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Serum Phosphate Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) (time frame: Day 1 to Day 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02151643, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.