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

ISRCTN	ISRCTN24741445
DOI	https://doi.org/10.1186/ISRCTN24741445
Secondary identifying numbers	14591

Submission date: 16/01/2014
Registration date: 16/01/2014
Last edited: 10/02/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Alastair Hutchison
Scientific

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Phone	+44 161 276 7974
Email	Alastair.Hutchison@cmft.nhs.uk

Study information

Study design	Randomised; Interventional; Design type: Process of Care, Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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 acronym	SPIRiT
Study objectives	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(s)	13/EM/0052
Health condition(s) or problem(s) studied	Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal
Intervention	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	Other
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 study start date	06/03/2013
Completion date	31/12/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 120; UK Sample Size: 120
Total final enrolment	104
Key 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
Key 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
Date of first enrolment	27/05/2013
Date of final enrolment	31/03/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Manchester Royal Infirmary

Manchester
M13 9WL
United Kingdom

Sponsor information

Central Manchester University Hospitals NHS Trust (CMFT) (UK)
Hospital/treatment centre

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

"ROR"	https://ror.org/00he80998

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/09/2015		Yes	No
Results article	results	04/02/2019	10/02/2020	Yes	No
HRA research summary			28/06/2023	No	No

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.