Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Alastair Hutchison


Contact details

Manchester Royal Infirmary
Oxford Road
M13 9WL
United Kingdom
+44 161 276 7974

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A feasibility study to inform the design of a national multi-centre RCT to evaluate if reducing serum phosphate to normal levels improves clinical outcomes including mortality, cardiovascular events, bone pain or fracture in patients on dialysis



Study hypothesis

Dialysis patients have a very high death rate; circumstantial evidence suggests this may be related to increased levels of phosphate in their blood, but conclusive evidence is lacking. There is currently no definite proof that reducing blood levels of phosphate is beneficial to dialysis patients. Therefore discussions between clinicians and patients lack a sound evidence base. Existing methods of reducing phosphate levels require control of diet/food intake, swallowing large numbers of unpalatable large tablets and/or lengthening the time of dialysis treatments. Consequently patients (and clinicians) have identified phosphate self-management as complicated and difficult, and are unsure how worthwhile it is to their long-term health. A large randomised controlled trial (~3000 patients randomised 50:50 to either lower phosphate or higher phosphate ranges for 3+ years) is required to answer the key question "Would reducing phosphate levels improve the length of dialysis patients' lives?" However, whether such a trial is technically possible is unknown, and therefore we are conducting a feasibility study (120 patients over 24 months) to inform the design and conduct of a future, definitive trial. This feasibility study will assess:

1. The effectiveness of a stepped approach to achieving 'lower/normal' serum phosphate levels, and the possibility of achieving clear separation by serum phosphate between the 'lower range' and 'higher range' groups.

2. Willingness of patients to be randomised,

3. Willingness of clinicians to recruit participants in a trial that includes 'higher range' serum phosphate control are they convinced that this is acceptable?

4. The symptoms scores for each group.

5. Likely number of eligible patients, recruitment timescale and drop-out rates.

The outcome of this feasibility study will be used to design the larger multicentre study; its results will have major implications for self-management by dialysis patients.

Ethics approval


Study design

Randomised; Interventional; Design type: Process of Care, Treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal


Communicare: This is a self help computer package to encourage adherance to oral phosphate binders.
Dietician review: This is done in the washout period
Modified BAASIS: This is a questionnaire which is administered every 4 weeks in the study to encourage adherence
Oral phosphate binders: These are Lanthanum and Sevelamer. They are normally used as part of routine clinical care in dialysis patients.
PDSI: Pittsborough Dialysis Symptom Index - This is a symptom score which is administered at 3 time points in the study.

Intervention type



Not Applicable

Drug names

Primary outcome measure

Feasibility; Timepoint(s): End of the study - Is a large national multi-centre RCT feasible?

Secondary outcome measures

1. Adherance; Timepoint(s): End of the study
2. Consent; Timepoint(s): End of the study - Percentage Suitable Vs Percentage consented
3. Drop out rate; Timepoint(s): End of the study
4. Event rate; Timepoint(s): End of the study
5. Pill burden; Timepoint(s): End of the study
6. Renal physicians; Timepoint(s): End of the study - Percentage of renal physoicians willing to let their patients enroll
7. Suitability; Timepoint(s): Percentage of total dialysis population found suitable - End of the study
8. Target Phosphate; Timepoint(s): End of the study - Percentage who achieved target serum phosphate

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Male and female patients aged 30 years or above, on dialysis for at least 6 months, under the supervision of Central Manchester University Hospitals Foundation Trust (CMFT) or Salford Royal NHS Foundation Trust (SRFT)
2. Serum phosphate level of 1.8mmol/L or greater after washout (discontinuation) of previous phosphate binding medication
3. Able to achieve Renal Association standards for quality of dialysis
4. Able to communicate in English ('Communicare' package is available only in English)
5. Able to consent

Participant type


Age group




Target number of participants

Planned Sample Size: 120; UK Sample Size: 120

Total final enrolment


Participant exclusion criteria

1. Living donor renal transplant planned in the next 12 months
2. Serum parathyroid hormone greater than 800 pg/ml (85 pmol/L)on 2 consecutive 3-monthly blood tests. Such patients probably have uncontrolled hyperparathyroidism which adversely influences serum phosphate levels, and needs treatment in its own right
3. Known intolerance of oral sevelamer and lanthanum carbonate
4. Medical history that might limit the individual's ability to take the trial treatments for the duration of the study (e.g. history of cancer other than non-melanoma skin cancer, or recent history of alcohol or substance misuse)
5. Patients aged below 30 years have a low rate of vascular events and will not be recruited

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Manchester Royal Infirmary
M13 9WL
United Kingdom

Sponsor information


Central Manchester University Hospitals NHS Trust (CMFT) (UK)

Sponsor details

Genetic Medicine
Manchester Royal Infirmary
Oxford Road
M13 9WL
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0711-25112

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2015 protocol in:
2020 results in (added 10/02/2020)

Publication citations

Additional files

Editorial Notes

10/02/2020: The following changes have been made: 1. Publication reference added. 2. The total final enrolment number has been added from the reference. 19/06/2017: The overall trial dates have been updated from 01/05/2013 - 31/12/2013 to 06/03/2013 - 31/12/2016 and the recruitment dates have bee updated from 01/05/2013 - 31/12/2013 to 27/05/2013 - 31/03/2014.