Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/10/2013
Date assigned
11/12/2013
Last edited
26/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
End-stage renal disease (ESRD) or chronic kidney disease occurs when the kidneys have lost all or
almost all of their ability to filter excess fluid and waste products from the body. Almost all patients with ESRD also have secondary hyperparathyroidism (SHPT), which is the excessive release of parathyroid hormone (PTH) by the parathyroid glands (small glands in the neck) in response to low blood calcium levels and abnormal growth of these glands. SHPT causes calcium levels to rise and phosphorus levels to fall, leading to abnormal levels in a patient’s blood. Uncontrolled SHPT is associated with an increased risk of death in patients with ESRD. However, currently there is no data available about what happens when control is achieved for a number of markers of the disease (which include levels of calcium and phosphorus) within the same patient. In addition there is limited knowledge of the patterns of how SHPT is treated in normal clinical practice and their associated treatment costs. This study aims to describe the management of secondary hyperparathyroidism (SHPT) in the UK NHS with a focus on the renal unit service structure and policies, treatments, prescribing patterns and the costs and outcomes achieved. SHPT management will be explored in reference to the existing UK Renal Association Clinical Guidelines, the National Kidney Federation Kidney Disease Outcome Quality Initiative (KDOQI) guidelines and the Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline. There are a number of medications available to physicians to control the levels of the disease markers. However, currently there is limited availability of both the medication cinacalcet (a drug that mimics the action of calcium with body tissues) and also a group of medications known as ‘non-calcium containing phosphate binders’. There is a perception that this availability varies considerably from hospital to hospital due to local funding policies. As such, there is an interest in understanding what triggers a physician to prescribe cinacalcet and non-calcium containing phosphate binders in the UK.

Who can participate?
Patients currently undergoing haemodialysis or peritoneal dialysis (types of treatments for kidney
failure) are eligible for participation. Patients are not eligible if they have been undergoing dialysis for less than 90 days at the start of data collection.

What does the study involve?
Data will be collected from medical records of patients and through review of written Trust / department policies and staff complement / staffing structure / organisational diagram documents. Data about the clinical management of patients will be extracted from renal unit databases and paper-based medical records.

What are the possible benefits and risks of participating?
Patients will not participate directly in this study. Inclusion of a patient’s medical records in this review will cause no additional risk for the patient, as their inclusion involves no further diagnosis, assessment or therapeutic practice other than that considered appropriate by his/her physician. As patients are not directly participating in the study, there are no direct benefits. However, it is anticipated that their data will help to improve care and patient outcomes for SHPT.

Where is the study run from?
Data will be collected from Renal Units in Addenbrooke’s Hospital, Cambridge; Birmingham Heartlands Hospital; Doncaster Royal Infirmary; Freeman Hospital, Newcastle; Ninewells Hospital, Dundee; Northern General Hospital, Sheffield; Royal Devon and Exeter Hospital and Southend Hospital. The Chief Investigator (Dr Nicholas Pritchard) is based at Addenbrooke’s Hospital, Cambridge.

When is study starting and how long is it expected to run for?
The study started in June 2011 and finished in November 2011.

Who is funding the study?
Amgen sponsored this research study.

Who is the main contact?
Dr Nicholas Pritchard
nick.pritchard@addenbrookes.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicholas Pritchard

ORCID ID

Contact details

Addenbrooke‟s Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20090260

Study information

Scientific title

A cross-sectional survey of the current management of secondary hyperparathyroidism in patients with end-stage renal disease undergoing dialysis in the UK NHS

Acronym

Study hypothesis

There were no hypotheses for this study, as this was an observational study. SHPT has a considerable impact on the morbidity and mortality of patients with end-stage renal disease. Although the UK Renal Registry report provides comprehensive data on achievement of single markers of disease control there is no data available that describes achievement of multiple markers of disease control within the same patient; it might be argued that this is a more important measure. Similarly, longitudinal data describing achievement of disease marker targets is not available. In addition there is limited knowledge regarding the patterns of treatment for SHPT in normal clinical practice and their associated treatments costs. Currently there is restricted availability of both cinacalcet and non-calcium containing phosphate binders with a perception that this availability differs widely from renal unit to renal unit due to local funding policies. There is interest in understanding the triggers for prescription of cinacalcet and non-calcium containing phosphate binders in the UK in terms of clinical and treatment history.

Ethics approval

NRES Committee East of England - Cambridge South, 11/03/2011, REC refrence number: 11/EE/0043

Study design

Observational retrospective multi-centre cross-sectional survey in secondary care

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Secondary hyperparathyroidism

Intervention

Data regarding renal unit service structure and local policies relating to SHPT management were obtained through review of written Trust/department policies and staff complement /staffing structure/organisational diagram documents. Data regarding the clinical management of patients was extracted from renal unit databases and paper-based medical records. All data was sourced from written policy and staffing documents or the hospital Trust computer systems and patients‟ hospital medical notes in the hospital Trusts. No treatment was given, and there was no direct contact with patients. The period of data collection / observation was between 6th June 2011 to 22 November 2011 (twenty-five weeks).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

N/A - observational study

Secondary outcome measures

N/A - observational study

Overall trial start date

06/06/2011

Overall trial end date

22/11/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients undergoing haemodialysis or peritoneal dialysis with a PTH greater than 15pMol for at least one reading in the 12 months prior to the data collection period.
2. Patients with a PTH 15pMol or less who have been prescribed a phosphate binder within the 12 months prior to the data collection period.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Target number = 1800-3000, final number = 2361

Participant exclusion criteria

Patients undergoing dialysis for less than 90 days prior to the data collection period.

Recruitment start date

06/06/2011

Recruitment end date

22/11/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke‟s Hospital
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Amgen Limited (UK)

Sponsor details

c/o Becky Wiggs
Medical Department
Amgen Limited
240 Cambridge Science Park
Milton Road
Cambridge
CB4 0WD
United Kingdom

Sponsor type

Industry

Website

http://www.amgen.co.uk/

Funders

Funder type

Industry

Funder name

This trial was sponsored by Amgen UK and Ireland (study number: 20090260).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Amgen Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cambridge Science Park

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Milton Road

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cambridge

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

CB4 0WD

Alternative name(s)

Funding Body Type

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Location

Funder name

Tel: +44 (0)1223 420305

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fax: +44 (0)1223 426314

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/10/2016: No publications found, verifying study status with principal investigator