Contact information
Type
Scientific
Primary contact
Dr Alastair Hutchison
ORCID ID
Contact details
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
+44 161 276 7974
Alastair.Hutchison@cmft.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14591
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
Acronym
SPIRiT
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
13/EM/0052
Study design
Randomised; Interventional; Design type: Process of Care, Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
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
06/03/2013
Overall trial end date
31/12/2016
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 120; UK Sample Size: 120
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
27/05/2013
Recruitment end date
31/03/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Manchester Royal Infirmary
Manchester
M13 9WL
United Kingdom
Funders
Funder type
Government
Funder name
NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0711-25112
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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: http://www.ncbi.nlm.nih.gov/pubmed/26366297