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

Not Applicable

Completed

• Conditions: Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal; Urological and Genital Diseases

• Registration Number: ISRCTN24741445
• Lead Sponsor: Central Manchester University Hospitals NHS Trust (CMFT) (UK)

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26366297 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/30717691 (added 10/02/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-16
• Study Completion: 2016-12-31
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 104

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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