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Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE) (PHOSPHATE)

Primary Purpose

Kidney Failure, Chronic, Hyperphosphatemia

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Liberal phosphate target
Intensive phosphate target
Sponsored by
The University of Queensland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring Renal dialysis, Randomised controlled trial, Bone markers, Cardiovascular risk factors, Phosphate lowering agent, End stage kidney disease, Hyperphosphatemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥45 years, or Age ≥18 years with diabetes,
  2. ESKD on haemodialysis or peritoneal dialysis, for at least 3 months,
  3. Currently prescribed at least one phosphate-lowering medication at any dose
  4. Able to provide informed consent

Exclusion Criteria:

  1. Elective kidney transplantation scheduled,
  2. Concomitant major illness / comorbidity that may result in death in the next 6 months in the view of the treating physician,
  3. Participation in an interventional study that is likely to affect serum phosphate concentration.

Sites / Locations

  • Royal Prince Alfred HosptialRecruiting
  • Nepean HospitalRecruiting
  • St George HospitalRecruiting
  • Royal North Shore HospitalRecruiting
  • Western Sydney Renal ServiceRecruiting
  • Wollongong HospitalRecruiting
  • Sunshine Coast University HospitalRecruiting
  • Royal Brisbane and Women's HospitalRecruiting
  • Princess Alexandra HospitalRecruiting
  • Bundaberg HospitalRecruiting
  • Cairns HospitalRecruiting
  • Fraser Coast Renal ServiceRecruiting
  • Mackay HospitalRecruiting
  • Logan HospitalRecruiting
  • Gold Coast University HospitalRecruiting
  • Central and Northern Adelaide Renal and Transplant ServiceRecruiting
  • Flinders Medical CentreRecruiting
  • Austin HealthRecruiting
  • Royal Melbourne HospitalRecruiting
  • St Vincent's Hospital MelbourneRecruiting
  • Latrobe Regional HospitalRecruiting
  • Armadale HospitalRecruiting
  • Sociedade Hospitalar Angelina Caron
  • Hospital de Clinicas Porto AlegreRecruiting
  • Foothills Hospital/ U of CalgaryRecruiting
  • Alberta Health ServicesRecruiting
  • St. Paul's HospitalRecruiting
  • Vancouver General HospitalRecruiting
  • Dalhousie UniversityRecruiting
  • Queen's UniversityRecruiting
  • London Health Sciences CentreRecruiting
  • Oakville Trafalgar Memorial HospitalRecruiting
  • Orillia Soldier's Memorial HospitalRecruiting
  • Lakeridge HealthRecruiting
  • The Ottawa HospitalRecruiting
  • Scarborough Hospital NetworkRecruiting
  • St Michael's HospitalRecruiting
  • University Health Network - University of TorontoRecruiting
  • St. Joseph's Healthcare HamiltonRecruiting
  • St. Joseph's Healthcare TorontoRecruiting
  • The Charles Lemoyne HospitalRecruiting
  • McGill University Health CentreRecruiting
  • Hopital Maisonneuve RosemontRecruiting
  • CHUMRecruiting
  • Jewish General HospitalRecruiting
  • Sacre Coeur HospitalRecruiting
  • CHU de Quebec Universite LavalRecruiting
  • Centre Hospitalier Universitaire de SherbrookeRecruiting
  • Auckland City Hospital
  • Christchurch Hospital
  • Dunedin Hospital
  • Waikato DHB
  • Hawkes Bay Hospital
  • Middlemore Hospital
  • Waitematā Hospital
  • Northland DHB
  • Cambridge University Hospitals NHS Foundation TrustRecruiting
  • University Hospitals Plymouth NHS TrustRecruiting
  • Dorset County Hospital NHS Foundation TrustRecruiting
  • South Tyneside And Sunderland NHS Foundation TrustRecruiting
  • East and North Hertfordshire NHS TrustRecruiting
  • East Kent Hospitals University NHS Foundation TrustRecruiting
  • NHS Greater Glasgow and ClydeRecruiting
  • James Paget University Hospitals NHS Foundation TrustRecruiting
  • NHS LanarkshireRecruiting
  • South Tees Hospitals NHS Foundation TrustRecruiting
  • York and Scarborough Teaching Hospitals NHS Foundation TrustRecruiting
  • Nottingham University Hospitals NHS TrustRecruiting
  • NHS HighlandRecruiting
  • Shrewsbury and Telford Hospital NHS TrustRecruiting
  • Sheffield Teaching Hospitals NHS Foundation TrustRecruiting
  • University Hospital of North Midlands NHS TrustRecruiting
  • West Suffolk HospitalRecruiting
  • University Hospitals Sussex NHS Foundation TrustRecruiting
  • Bradford Teaching Hospital NHS Foundation TrustRecruiting
  • Wirral University Teaching Hospital NHS Foundation TrustRecruiting
  • Gloucestershire Hospital NHS Foundation TrustRecruiting
  • Royal Devon and Exeter NHS Foundation TrustRecruiting
  • University Hospitals Of Leicester NHS TrustRecruiting
  • Guy's and St Thomas' NHS Foundation TrustRecruiting
  • King's College Hospital NHS Foundation TrustRecruiting
  • St George's University Hospitals NHS Foundation TrustRecruiting
  • Manchester University NHS Foundation TrustRecruiting
  • The Newcastle Upon Tyne Hospitals NHS Foundation TrustRecruiting
  • Royal Berkshire NHS Foundation TrustRecruiting
  • Mid and South Essex NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Liberal phosphate target

Intensive phosphate target

Arm Description

Liberal serum phosphate target of 2.0 to 2.5 mmol/L.

Intensive serum phosphate target of ≤1.50 mmol/L.

Outcomes

Primary Outcome Measures

Time to a composite endpoint of cardiovascular death or non-fatal major cardiovascular event
Time to a composite endpoint of cardiovascular death, non-fatal myocardial infarction or coronary revascularization, stroke, or peripheral arterial event.

Secondary Outcome Measures

Time to individual components of the primary composite endpoint,
Time to all-cause death
Utility-based quality of life EQ5D-5L
EQ5D-5L will be used to assess patient self-reported quality of life measures.

Full Information

First Posted
May 20, 2018
Last Updated
October 11, 2023
Sponsor
The University of Queensland
Collaborators
National Health and Medical Research Council, Australia, Applied Health Research Centre, Cambridge University Hospitals NHS Foundation Trust, University of Otago
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1. Study Identification

Unique Protocol Identification Number
NCT03573089
Brief Title
Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
Acronym
PHOSPHATE
Official Title
An Investigator-initiated, International, Multi-centre, Prospective, Randomized, Open-label, Parallel-group, Superiority, and Pragmatic Large Simple Trial (LST) to Determine Whether the Currently Recommended Strategy of Intensive Reduction of Serum Phosphate Concentration Towards the Normal Level Results in Significant Patient-centred Benefits in End-stage Kidney Disease (ESKD) Patients Receiving Dialysis.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Queensland
Collaborators
National Health and Medical Research Council, Australia, Applied Health Research Centre, Cambridge University Hospitals NHS Foundation Trust, University of Otago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
During end-stage kidney disease, clinical guidelines suggest reducing elevated phosphate levels in the blood. However, the effect of lowering blood phosphate levels on important patient-centred outcomes has never been tested. This trial will evaluate whether compared to high levels, lowering blood phosphate levels would reduce death or major events due to heart disease, improve physical health, and be cost-effective.
Detailed Description
Hyperphosphataemia is highly prevalent in patients with end-stage kidney disease (ESKD) and associated with increased mortality risk. The Clinical Practice Guidelines suggest lowering elevated phosphate levels towards the normal range (level 2C suggestion). However, trial data demonstrating that treatments that lower serum phosphate will improve patient-centred outcomes are lacking. The primary objective is to test the hypothesis that compared to a liberal serum phosphate concentration target of 2.0 to 2.5 mmol/L, intensive lowering of serum phosphate towards the normal level (≤1.50 mmol/L) with phosphate binders reduces the risk of fatal or non-fatal major cardiovascular events in ESKD patients receiving dialysis. The secondary objectives are to test the hypothesis that intensive lowering of serum phosphate towards the normal level with phosphate binders would improve physical health, fatigue, health-related quality of life, patient satisfaction, and pruritus; and be cost-effective. In this pragmatic, multinational, randomised controlled large simple trial, a total of 3600 adult ESKD patients receiving dialysis will be randomised either to intensive (≤1.50 mmol/L) or liberalized (2.0-2.5 mmol/L) serum phosphate target. The choice and dose of phosphate binders will be at the treating physician's discretion and local practice to achieve and maintain serum phosphate concentration within the required target range according to randomisation. The primary endpoint is the composite endpoint of cardiovascular death, non-fatal major cardiovascular or peripheral arterial events. The secondary outcome measures will be individual components of the primary composite endpoint, all-cause death, and utility-based quality of life EQ5D-5L.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic, Hyperphosphatemia
Keywords
Renal dialysis, Randomised controlled trial, Bone markers, Cardiovascular risk factors, Phosphate lowering agent, End stage kidney disease, Hyperphosphatemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liberal phosphate target
Arm Type
Active Comparator
Arm Description
Liberal serum phosphate target of 2.0 to 2.5 mmol/L.
Arm Title
Intensive phosphate target
Arm Type
Experimental
Arm Description
Intensive serum phosphate target of ≤1.50 mmol/L.
Intervention Type
Drug
Intervention Name(s)
Liberal phosphate target
Intervention Description
All phosphate-lowering medications in use at baseline will be discontinued. Phosphate-lowering medications will be prescribed only if serum phosphate concentration exceeds 2.50 mmol/L. The choice and dosages of phosphate-lowering medications will be at the discretion of treating physicians and/or participants.
Intervention Type
Drug
Intervention Name(s)
Intensive phosphate target
Intervention Description
This will be achieved by prescribing phosphate-lowering medications aimed to intensively lower serum phosphate concentration towards normal level (≤1.50 mmol/L). The choice and dosages of phosphate-lowering medications will be at the discretion of treating physicians and/or participants.
Primary Outcome Measure Information:
Title
Time to a composite endpoint of cardiovascular death or non-fatal major cardiovascular event
Description
Time to a composite endpoint of cardiovascular death, non-fatal myocardial infarction or coronary revascularization, stroke, or peripheral arterial event.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Time to individual components of the primary composite endpoint,
Time Frame
5 years
Title
Time to all-cause death
Time Frame
5 years
Title
Utility-based quality of life EQ5D-5L
Description
EQ5D-5L will be used to assess patient self-reported quality of life measures.
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Differences in the serum concentrations of phosphate, PTH, calcium, alkaline phosphatase and albumin
Time Frame
Time Frame: 5 years
Title
Phosphate-lowering medication usage
Time Frame
5 years
Title
Phosphate-lowering medication self-reported adherence
Time Frame
5 years
Title
Proportion of patients requiring parathyroidectomy
Time Frame
5 years
Title
Proportion of patients developing calciphylaxis
Time Frame
5 years
Title
Gastrointestinal Symptom Rating Scale
Description
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item instrument designed to assess the symptoms associated with common GI disorders. It has five subscales (reflux, diarrhea, constipation, abdominal pain and indigestion). Subscale scores range from 1-7 and higher scores represent higher symptom burden i.e. more discomfort.
Time Frame
5 years
Title
Itch/pruritus visual analog scale
Description
The Pruritis 5-D scale contains five domains: duration, degree, direction, disability and distribution. The scores of each of the five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritus) and 25 (most severe pruritus).
Time Frame
5 years
Title
Cost-effectiveness analysis:
Description
Difference in the incremental cost per Quality Adjusted Life Years gained
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥45 years, or Age ≥18 years with diabetes, ESKD on haemodialysis or peritoneal dialysis, for at least 3 months, Currently prescribed at least one phosphate-lowering medication at any dose Able to provide informed consent Exclusion Criteria: Elective kidney transplantation scheduled, Concomitant major illness / comorbidity that may result in death in the next 6 months in the view of the treating physician, Participation in an interventional study that is likely to affect serum phosphate concentration.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ron Wald
Phone
+1 416-867-3703
Email
WaldR@smh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Rona Smith
Phone
+44 07929642380
Email
rms50@cam.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Badve
Organizational Affiliation
The University of Queensland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ron Wald
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rona Smith
Organizational Affiliation
University of Cambridge
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suetonia Palmer
Organizational Affiliation
University of Otago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick Mark
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rathika Krishnasamy
Organizational Affiliation
The University of Queensland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Walsh
Organizational Affiliation
Hamilton Centre for Kidney Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Prince Alfred Hosptial
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Snelling, Dr
Email
Paul.Snelling@health.nsw.gov.au
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2750
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muralikrishna Komala, Dr
Email
Muralikrishna.GangadharanKomala@health.nsw.gov.au
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunil Badve, A/Prof
Email
s.badve@unsw.edu.au
Facility Name
Royal North Shore Hospital
City
Saint Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma O'Lone, Dr
Email
emma.olone@health.nsw.gov.au
Facility Name
Western Sydney Renal Service
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grahame Elder, A/Prof
Email
grahame.j.elder@gmail.com
Facility Name
Wollongong Hospital
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hichaim Cheikh Hasan, Dr
Email
HichamIbrahim.CheikhHassan@health.nsw.gov.au
Facility Name
Sunshine Coast University Hospital
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rathika Krishnasamy, A/Prof
Email
Rathika.Krishnasamy@health.qld.gov.au
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharad Ratanjee, Dr
Email
sharad.ratanjee@health.qld.gov.au
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4110
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmel Hawley, Prof
Email
Carmel.Hawley@health.qld.gov.au
Facility Name
Bundaberg Hospital
City
Bundaberg
State/Province
Queensland
ZIP/Postal Code
4670
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clyson Mutatiri, Dr
Email
Clyson.Mutatiri@health.qld.gov.au
Facility Name
Cairns Hospital
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shyam Dheda, Dr
Email
Shyam.Dheda@health.qld.gov.au
Facility Name
Fraser Coast Renal Service
City
Hervey Bay
State/Province
Queensland
ZIP/Postal Code
4655
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krishan Madhan, Dr
Email
Krishan.Madhan@health.qld.gov.au
Facility Name
Mackay Hospital
City
Mackay
State/Province
Queensland
ZIP/Postal Code
4740
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roy Cherian, Dr
Email
roy.cherian@health.qld.gov.au
Facility Name
Logan Hospital
City
Meadowbrook
State/Province
Queensland
ZIP/Postal Code
4131
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken-Soon Tan, Dr
Email
ken-soon.tan@health.qld.gov.au
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siddarth Sharma, Dr
Email
Siddharth.Sharma@health.qld.gov.au
Facility Name
Central and Northern Adelaide Renal and Transplant Service
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phillip Clayton, Dr
Email
Phil@anzdata.org.au
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Milton, Dr
Email
caroline.milton@sa.gov.au
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Mount, Dr
Email
Peter.MOUNT@austin.org.au
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nigel Toussaint, Prof
Facility Name
St Vincent's Hospital Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Ford, Dr
Email
sharon.ford@svha.org.au
Facility Name
Latrobe Regional Hospital
City
Traralgon
State/Province
Victoria
ZIP/Postal Code
3844
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Solomon Menahem, Dr
Email
solomon.menahem@monash.edu
Facility Name
Armadale Hospital
City
Armadale
State/Province
Western Australia
ZIP/Postal Code
6112
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hemant Kulkarni, Dr
Email
hemant.kulkarni@health.wa.gov.au
Facility Name
Sociedade Hospitalar Angelina Caron
City
Campina Grande
State/Province
Paraíba
ZIP/Postal Code
58407-350
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Hospital de Clinicas Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Saldanha Thome, Dr
Email
fthome@hcpa.edu.br
Facility Name
Foothills Hospital/ U of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis Girard
Email
Louis.girard@albertahealthservices.ca
Facility Name
Alberta Health Services
City
Edmonton
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mercedech Kiaii
Email
mkiaii@providencehealth.bc.ca
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Harris, Dr
Facility Name
Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4R2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karthik Tennankore
Email
KarthikK.tennankore@nshealth.ca
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Silver
Email
Samuel.silver@queensu.ca
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Weir
Email
Matthew.weir@lhsc.on.ca
Facility Name
Oakville Trafalgar Memorial Hospital
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6M 0L8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danny Sapir
Email
dsapir@haltonhealthcare.com
Facility Name
Orillia Soldier's Memorial Hospital
City
Orillia
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Tascona, Dr
Facility Name
Lakeridge Health
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Steele
Email
asteele@lh.ca
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Swapnil Hiremath
Email
shiremath@toh.ca
Facility Name
Scarborough Hospital Network
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1P 2V5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Tam
Email
pywtam@gmail.com
Facility Name
St Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ron Wald, Dr
Phone
416-867-3703
Email
Ron Wald <Ron.Wald@unityhealth.to>
Facility Name
University Health Network - University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1L7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charmaine Lok
Email
charmaine.lok@uhn.ca
Facility Name
St. Joseph's Healthcare Hamilton
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6R 1B5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Walsh, Dr
Phone
905-522-1155
Ext
34055
Email
lastwalsh1975@gmail.com
Facility Name
St. Joseph's Healthcare Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6R 1B5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna Sasal
Email
Joanna.sasal@unityhealth.to
Facility Name
The Charles Lemoyne Hospital
City
Longueuil
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominic Poirier, Dr
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita Suri
Email
Rsuri.kidney@gmail.com
Facility Name
Hopital Maisonneuve Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie-Claire Nadeau-Fredette
Email
acnadeau-fredette.hmr@ssss.gouv.qc.ca
Facility Name
CHUM
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Beaubien
Email
william.beaubien@gmail.com
First Name & Middle Initial & Last Name & Degree
Marie-Line Caron
Email
marie-line.caron.chum@ssss.gouv.qc.ca
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Blum
Email
Daniel.blum@mail.mcgill.ca
Facility Name
Sacre Coeur Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Remi Goupil
Email
remi.goupil@umontreal.ca
Facility Name
CHU de Quebec Universite Laval
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice Mac-Way
Email
Fabrice.mac-way@chudequebec.ca
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Plaisance, Dr
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Dunedin Hospital
City
Dunedin
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Waikato DHB
City
Hamilton
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Hawkes Bay Hospital
City
Hastings
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Middlemore Hospital
City
Otahuhu
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Waitematā Hospital
City
Takapuna
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Northland DHB
City
Whangarei
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
Cambridgeshire
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Pritchard, Dr
Facility Name
University Hospitals Plymouth NHS Trust
City
Plymouth
State/Province
Devon
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilary Cramp, Dr
Facility Name
Dorset County Hospital NHS Foundation Trust
City
Dorchester
State/Province
Dorset
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alastair Hutchison, Prof
Facility Name
South Tyneside And Sunderland NHS Foundation Trust
City
Sunderland
State/Province
Durham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Davison, Dr
Facility Name
East and North Hertfordshire NHS Trust
City
Stevenage
State/Province
Hertfordshire
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enric Vilar, Dr
Facility Name
East Kent Hospitals University NHS Foundation Trust
City
Canterbury
State/Province
Kent
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Delaney, Dr
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
State/Province
Kent
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sokratis Stoumpos, Dr
Facility Name
James Paget University Hospitals NHS Foundation Trust
City
Great Yarmouth
State/Province
Norfolk
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Patrick, Dr
Facility Name
NHS Lanarkshire
City
Airdrie
State/Province
North Lanarkshire
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoe Cousland, Dr
Facility Name
South Tees Hospitals NHS Foundation Trust
City
Middlesbrough
State/Province
North Yorkshire
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Hoye, Dr
Facility Name
York and Scarborough Teaching Hospitals NHS Foundation Trust
City
York
State/Province
North Yorkshire
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santhanakrishnan Balasubramanian, Dr
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
Nottinghamshire
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Bebb, Dr
Facility Name
NHS Highland
City
Inverness
State/Province
Scotland
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stewart Lambie, Dr
Facility Name
Shrewsbury and Telford Hospital NHS Trust
City
Shrewsbury
State/Province
Shropshire
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Eardley, Dr
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
State/Province
South Yorkshire
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Curran, Dr
Facility Name
University Hospital of North Midlands NHS Trust
City
Stoke-on-Trent
State/Province
Staffordshire
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Davies, Prof
Facility Name
West Suffolk Hospital
City
Bury St Edmunds
State/Province
Suffolk
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Pritchard, Dr
Facility Name
University Hospitals Sussex NHS Foundation Trust
City
Brighton
State/Province
Sussex
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farid Ghalli, Dr
Facility Name
Bradford Teaching Hospital NHS Foundation Trust
City
Bradford
State/Province
West Yorkshire
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarun Bansai, Dr
Facility Name
Wirral University Teaching Hospital NHS Foundation Trust
City
Birkenhead
State/Province
Wirral
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Ledson, Dr
Facility Name
Gloucestershire Hospital NHS Foundation Trust
City
Cheltenham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madhu Potluri, Dr
Facility Name
Royal Devon and Exeter NHS Foundation Trust
City
Exeter
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Coralie Bingham, Dr
Facility Name
University Hospitals Of Leicester NHS Trust
City
Leicester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Burton, Dr
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Robson, Dr
Facility Name
King's College Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Alston, Dr
Facility Name
St George's University Hospitals NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vasantha Muthuppalaniappan, Dr
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandip Mitra, Prof
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
City
Newcastle Upon Tyne
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suren Kanagasundaram, Dr
Facility Name
Royal Berkshire NHS Foundation Trust
City
Reading
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassam Alchi, Dr
Facility Name
Mid and South Essex NHS Foundation Trust
City
Southend-on-Sea
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Yin Keet Chan, Dr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures and appendices) will be available for individual participant data meta-analysis.
IPD Sharing Time Frame
Beginning 2 years and ending 5 years following main publication. Proposals may be submitted up to 5 years following article publication. After 5 years, the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
IPD Sharing Access Criteria
An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.
Links:
URL
http://aktn.org.au/
Description
Australasian Kidney Trials Network Website

Learn more about this trial

Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)

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