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

June 29, 2025 updated by: The University of Queensland

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

3600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ron Wald
  • Phone Number: 416 867 3703
  • Email: WaldR@smh.ca

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Active, not recruiting
        • Royal Prince Alfred Hosptial
      • Kingswood, New South Wales, Australia, 2750
        • Active, not recruiting
        • Nepean Hospital
      • Kogarah, New South Wales, Australia, 2217
        • Active, not recruiting
        • St George Hospital
      • Saint Leonards, New South Wales, Australia, 2065
        • Active, not recruiting
        • Royal North Shore Hospital
      • Westmead, New South Wales, Australia, 2145
        • Active, not recruiting
        • Western Sydney Renal Service
      • Wollongong, New South Wales, Australia, 2500
        • Active, not recruiting
        • Wollongong Hospital
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Active, not recruiting
        • Sunshine Coast University Hospital
      • Brisbane, Queensland, Australia, 4006
        • Active, not recruiting
        • Royal Brisbane and Women's Hospital
      • Brisbane, Queensland, Australia, 4110
        • Active, not recruiting
        • Princess Alexandra Hospital
      • Bundaberg, Queensland, Australia, 4670
        • Active, not recruiting
        • Bundaberg Hospital
      • Cairns, Queensland, Australia, 4870
        • Active, not recruiting
        • Cairns Hospital
      • Hervey Bay, Queensland, Australia, 4655
        • Active, not recruiting
        • Fraser Coast Renal Service
      • Mackay, Queensland, Australia, 4740
        • Active, not recruiting
        • Mackay Hospital
      • Meadowbrook, Queensland, Australia, 4131
        • Active, not recruiting
        • Logan Hospital
      • Southport, Queensland, Australia, 4215
        • Active, not recruiting
        • Gold Coast University Hospital
      • Townsville, Queensland, Australia, 4817
        • Active, not recruiting
        • Townsville University Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Active, not recruiting
        • Central and Northern Adelaide Renal and Transplant Service
      • Bedford Park, South Australia, Australia, 5042
        • Active, not recruiting
        • Flinders Medical Centre
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Active, not recruiting
        • Austin Health
      • Melbourne, Victoria, Australia, 3050
        • Active, not recruiting
        • Royal Melbourne Hospital
      • Melbourne, Victoria, Australia, 3065
        • Active, not recruiting
        • St Vincent's Hospital Melbourne
      • Traralgon, Victoria, Australia, 3844
        • Active, not recruiting
        • Latrobe Regional Hospital
    • Washington
      • Armadale, Washington, Australia, 6112
        • Active, not recruiting
        • Armadale Hospital
  • Brazil
      • Barro Preto, Brazil
        • Recruiting
        • Fundacao Felice Rosso - Hospital Felicio Rocho
        • Contact:
          • Lucas Filogonio
      • São Paulo, Brazil
        • Recruiting
        • Hospital Alemao Oswaldo Cruz
        • Contact:
          • Precil Diego M. de M. Neves
    • Paraná
      • Ponta Grossa, Paraná, Brazil, 84010-200
        • Recruiting
        • BRA Santa Casa de Misericórdia de Ponta Grossa
    • Paraíba
      • Campina Grande, Paraíba, Brazil, 58407-350
        • Recruiting
        • Sociedade Hospitalar Angelina Caron
        • Contact:
          • Dalton Bertolin Precoma
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Recruiting
        • Hospital de Clínicas Porto Alegre
        • Contact:
  • Canada
      • Red Deer, Canada
        • Recruiting
        • Red Deer Hospital;
        • Contact:
          • Sandeep Brar
      • Toronto, Canada
        • Recruiting
        • Humber River Hospital
        • Contact:
          • Gihad Nesrallah
      • Toronto, Canada
        • Recruiting
        • Michael Garron Hospital
        • Contact:
          • Nausheen Siddiqui
      • Toronto, Canada
        • Recruiting
        • Trillium Health Partners
        • Contact:
          • Vincent Ki
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
      • Edmonton, Alberta, Canada
        • Recruiting
        • Alberta Health Services
        • Contact:
          • David Collister
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Vancouver, British Columbia, Canada
        • Completed
        • Vancouver General Hospital
    • Nova Scotia
    • Ontario
      • Kingston, Ontario, Canada, K7L 3N6
      • London, Ontario, Canada, N6A 5W9
      • Oakville, Ontario, Canada, L6M 0L8
      • Orillia, Ontario, Canada
        • Recruiting
        • Orillia Soldier's Memorial Hospital
        • Contact:
          • Daniel Tascona, Dr
      • Oshawa, Ontario, Canada, L1G 2B9
        • Recruiting
        • Lakeridge Health
        • Contact:
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital
        • Contact:
      • Richmond Hill, Ontario, Canada
        • Recruiting
        • Mackenzie Health
      • Scarborough, Ontario, Canada, M1P 2V5
        • Recruiting
        • Scarborough Hospital Network
        • Contact:
      • Toronto, Ontario, Canada, M5B 1W8
      • Toronto, Ontario, Canada, M6R 1B5
        • Recruiting
        • St. Joseph's Healthcare Hamilton
        • Contact:
      • Toronto, Ontario, Canada, M6R 1B5
      • Toronto, Ontario, Canada, M5G 1L7
        • Recruiting
        • University Health Network - University of Toronto
        • Contact:
    • Quebec
      • Longueuil, Quebec, Canada
        • Recruiting
        • The Charles Lemoyne Hospital
        • Contact:
          • Dominic Poirier, Dr
      • Montreal, Quebec, Canada, 4A 3J1
      • Montréal, Quebec, Canada, H1T 2M4
      • Montréal, Quebec, Canada, H2W 1T8
      • Montréal, Quebec, Canada, H3T 1E2
      • Montréal, Quebec, Canada, H4J 1C5
      • Quebec City, Quebec, Canada, G1V 4G2
      • Sherbrooke, Quebec, Canada
        • Recruiting
        • Centre Hospitalier Universitaire de Sherbrooke
        • Contact:
          • Martin Plaisance, Dr
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Centre hospitalier universitaire de Sherbrooke (CHUS)
        • Contact:
          • Martin Plaisance
  • France
      • Paris, France
        • Recruiting
        • AURA Paris Plaisance
        • Contact:
          • Pablo Urena
  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Hadassah University
        • Contact:
          • Eyal Ophir
      • Jerusalem, Israel
        • Recruiting
        • Shaare Zedek Medical Centre
        • Contact:
          • Linda Shavit
      • Kfar Saba, Israel
        • Recruiting
        • Meir Hospital
        • Contact:
          • Keren Cohen
      • Ramat Gan, Israel
        • Recruiting
        • Sheba Hospital
        • Contact:
          • Pazit Beckerman
  • New Zealand
      • Auckland, New Zealand
        • Completed
        • Auckland City Hospital
      • Christchurch, New Zealand
        • Completed
        • Christchurch Hospital
      • Dunedin, New Zealand
        • Completed
        • Dunedin Hospital
      • Hamilton, New Zealand
        • Completed
        • Waikato DHB
      • Hastings, New Zealand
        • Completed
        • Hawkes Bay Hospital
      • Otahuhu, New Zealand
        • Completed
        • Middlemore Hospital
      • Takapuna, New Zealand
        • Completed
        • Waitematā Hospital
      • Whangarei, New Zealand
        • Completed
        • Northland DHB
  • Thailand
    • Khet Ratchathewi
      • Bangkok, Khet Ratchathewi, Thailand, 10400
  • United Kingdom
      • Birmingham, United Kingdom
        • Recruiting
        • University Hospital Birmingham NHS Foundation Trust
        • Contact:
          • Kolitha Basnayake, Dr
      • Cardiff, United Kingdom
        • Recruiting
        • Cardiff and Wales University Local Health Board
        • Contact:
          • Rhodri Pyart, Dr
      • Carlisle, United Kingdom
        • Recruiting
        • North Cumbria Integrated Care Nhs Foundation Trust
        • Contact:
          • Amer Hayat, Dr
      • Carshalton, United Kingdom
        • Recruiting
        • Epsom and St Helier University Hospitals NHS Trust
        • Contact:
          • Pauline Swift, Dr
      • Cheltenham, United Kingdom
        • Recruiting
        • Gloucestershire Hospital NHS Foundation Trust
        • Contact:
          • Madhu Potluri, Dr
      • Coventry, United Kingdom
        • Recruiting
        • University Hospitals Coventry & Warwickshire
        • Contact:
          • Waqar Ayub, Dr
      • Derby, United Kingdom
        • Recruiting
        • University Hospitals of Derby and Burton
        • Contact:
          • Nitin Kolhe, Dr
      • Doncaster, United Kingdom
        • Recruiting
        • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
        • Contact:
          • Ian Stott, Dr
      • Dudley, United Kingdom
        • Recruiting
        • The Dudley Group NHS Foundation Trust
        • Contact:
          • Kunigal Shivakumar, Dr
      • Exeter, United Kingdom
        • Recruiting
        • Royal Devon and Exeter NHS Foundation Trust
        • Contact:
          • Coralie Bingham, Dr
      • Hull, United Kingdom
        • Recruiting
        • Hull University Teaching Hospital NHS Trust
        • Contact:
          • Sunil Bhandari, Dr
      • Ipswich, United Kingdom
        • Recruiting
        • Ipswich Hospital (East Suffolk & North Essex Foundation Trust)
        • Contact:
          • Richard Smith, Dr
      • Leicester, United Kingdom
        • Recruiting
        • University Hospitals Of Leicester Nhs Trust
        • Contact:
          • James Burton, Dr
      • Liverpool, United Kingdom
        • Recruiting
        • University Hospital Aintree
        • Contact:
          • Christopher Glodsmith, Dr
      • Liverpool, United Kingdom
        • Recruiting
        • Royal Liverpool University Hospitals
        • Contact:
          • Anirudh Rao, Dr
      • London, United Kingdom
        • Recruiting
        • King's College Hospital NHS Foundation Trust
        • Contact:
          • Helen Alston, Dr
      • London, United Kingdom
        • Recruiting
        • Guy's and St Thomas' NHS Foundation Trust
        • Contact:
          • Mike Robson, Dr
      • London, United Kingdom
        • Recruiting
        • St George's University Hospitals NHS Foundation Trust
        • Contact:
          • Vasantha Muthuppalaniappan, Dr
      • Manchester, United Kingdom
        • Recruiting
        • Manchester University NHS Foundation Trust
        • Contact:
          • Sandip Mitra, Prof
      • Newcastle Upon Tyne, United Kingdom
        • Recruiting
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust
        • Contact:
          • Suren Kanagasundaram, Dr
      • Reading, United Kingdom
        • Recruiting
        • Royal Berkshire NHS Foundation Trust
        • Contact:
          • Bassam Alchi, Dr
      • Southend-on-Sea, United Kingdom
        • Recruiting
        • Mid and South Essex NHS Foundation Trust
        • Contact:
          • Anthony Yin Keet Chan, Dr
      • Wolverhampton, United Kingdom
        • Recruiting
        • The Royal Wolverhampton NHS Trust
        • Contact:
          • Kay Tan, Dr
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom
        • Recruiting
        • Cambridge University Hospitals NHS Foundation Trust
        • Contact:
          • Nicholas Pritchard, Dr
    • Devon
      • Plymouth, Devon, United Kingdom
        • Recruiting
        • University Hospitals Plymouth NHS Trust
        • Contact:
          • Hilary Cramp, Dr
    • Dorset
      • Dorchester, Dorset, United Kingdom
        • Recruiting
        • Dorset County Hospital Nhs Foundation Trust
        • Contact:
          • Joanne Taylor, Dr
    • Durham
      • Sunderland, Durham, United Kingdom
        • Recruiting
        • South Tyneside and Sunderland NHS Foundation Trust
        • Contact:
          • Rachel Davison, Dr
    • Hertfordshire
      • Stevenage, Hertfordshire, United Kingdom
        • Recruiting
        • East and North Hertfordshire NHS Trust
        • Contact:
          • Enric Vilar, Dr
    • Kent
      • Canterbury, Kent, United Kingdom
        • Recruiting
        • East Kent Hospitals University NHS Foundation Trust
        • Contact:
          • Mike Delaney, Dr
      • Glasgow, Kent, United Kingdom
        • Recruiting
        • NHS Greater Glasgow and Clyde
        • Contact:
          • Sokratis Stoumpos, Dr
    • Norfolk
      • Great Yarmouth, Norfolk, United Kingdom
        • Recruiting
        • James Paget University Hospitals NHS Foundation Trust
        • Contact:
          • Jean Patrick, Dr
    • North Lanarkshire
      • Airdrie, North Lanarkshire, United Kingdom
        • Recruiting
        • NHS Lanarkshire
        • Contact:
          • Zoe Cousland, Dr
    • North Yorkshire
      • Middlesbrough, North Yorkshire, United Kingdom
        • Recruiting
        • South Tees Hospitals NHS Foundation Trust
        • Contact:
          • Neil Hoye, Dr
      • York, North Yorkshire, United Kingdom
        • Recruiting
        • York and Scarborough Teaching Hospitals NHS Foundation Trust
        • Contact:
          • Santhanakrishnan Balasubramanian, Dr
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom
        • Recruiting
        • Nottingham University Hospitals NHS Trust
        • Contact:
          • Charlotte Bebb, Dr
    • Scotland
      • Inverness, Scotland, United Kingdom
        • Recruiting
        • Nhs Highland
        • Contact:
          • Stewart Lambie, Dr
    • Shropshire
      • Shrewsbury, Shropshire, United Kingdom
        • Recruiting
        • Shrewsbury and Telford Hospital NHS Trust
        • Contact:
          • Kevin Eardley, Dr
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom
        • Recruiting
        • Sheffield Teaching Hospitals NHS Foundation Trust
        • Contact:
          • Simon Curran, Dr
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, United Kingdom
        • Recruiting
        • University Hospital of North Midlands NHS Trust
        • Contact:
          • Madhavan Menon, Dr
    • Suffolk
      • Bury St Edmunds, Suffolk, United Kingdom
        • Recruiting
        • West Suffolk Hospital
        • Contact:
          • Nicholas Pritchard, Dr
    • Sussex
      • Brighton, Sussex, United Kingdom
        • Recruiting
        • University Hospitals Sussex NHS Foundation Trust
        • Contact:
          • Farid Ghalli, Dr
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom
        • Recruiting
        • Bradford Teaching Hospital NHS Foundation Trust
        • Contact:
          • Tarun Bansai, Dr
    • Wirral
      • Birkenhead, Wirral, United Kingdom
        • Recruiting
        • Wirral University Teaching Hospital NHS Foundation Trust
        • Contact:
          • Tom Ledson, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Liberal phosphate target
Liberal serum phosphate target of 2.0 to 2.5 mmol/L.
Drug: Liberal phosphate target
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.
Experimental: Intensive phosphate target
Intensive serum phosphate target of ≤1.50 mmol/L.
Drug: Intensive phosphate target
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to a composite endpoint of cardiovascular death or non-fatal major cardiovascular event
Time Frame: 5 years
Time to a composite endpoint of cardiovascular death, non-fatal myocardial infarction or coronary revascularization, stroke, or peripheral arterial event.
5 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in the serum concentrations of phosphate, PTH, calcium, alkaline phosphatase and albumin
Time Frame: Time Frame: 5 years
Time Frame: 5 years
Phosphate-lowering medication usage
Time Frame: 5 years
5 years
Phosphate-lowering medication self-reported adherence
Time Frame: 5 years
5 years
Proportion of patients requiring parathyroidectomy
Time Frame: 5 years
5 years
Proportion of patients developing calciphylaxis
Time Frame: 5 years
5 years
Gastrointestinal Symptom Rating Scale
Time Frame: 5 years
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.
5 years
Itch/pruritus visual analog scale
Time Frame: 5 years
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).
5 years
Cost-effectiveness analysis:
Time Frame: 5 years
Difference in the incremental cost per Quality Adjusted Life Years gained
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Queensland

Collaborators

National Health and Medical Research Council, Australia
Cambridge University Hospitals NHS Foundation Trust
University of Otago
Applied Health Research Centre

Investigators

  • Principal Investigator: Sunil Badve, The University of Queensland
  • Principal Investigator: Rona Smith, University of Cambridge
  • Principal Investigator: Patrick Mark, University of Glasgow
  • Principal Investigator: Rathika Krishnasamy, The University of Queensland
  • Principal Investigator: Michael Walsh, Hamilton Centre for Kidney Research
  • Principal Investigator: Suetonia Green, University of Otago
  • Principal Investigator: Ron Wald, St Michael's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2019

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

May 20, 2018

First Submitted That Met QC Criteria

June 18, 2018

First Posted (Actual)

June 29, 2018

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 29, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKTN 17.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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