End Stage Renal Disease Clinical Trial
— AlteredOfficial title:
Does ALlopurinol Regress lefT Ventricular Hypertrophy in End Stage REnal Disease: The ALTERED Study
Kidney patients on dialysis commonly die because of heart disease. One of the biggest
problems in their hearts is that the muscle wall of the heart thickens. This makes it less
efficient. We found in patients with mild kidney disease that a drug normally used to treat
gout (allopurinol) had the remarkable side effect of being able to reduce this thickening of
their heart wall. In this new study we aim to find out if this benefit of allopurinol also
occurs in severe kidney patients i.e. those on regular dialysis. We also are trying to
figure out the best dose of allopurinol to use. To do this we are planning a study where we
will recruit patients with kidney disease who are on dialysis. The 1st phase of the trial
will be to determine the best dose of allopurinol to use and the second phase will be to do
a clinical trial where patients will be randomly allocated to either this optimum dose of
allopurinol or a dummy medication (placebo) and will receive one year of treatment. They
will have a special scan of the heart using an MRI machine to measure the extent of
thickening of their heart muscle before they start on treatment and will have a further MRI
scan when their one year treatment finishes.
Phase 1- the dose finding study, will involve 10 patients who will have between 3 and 7
visits to the hospital scheduled around 4 to 17 dialysis sessions. The later study will
involve up to 76 patients who will be asked to attend the hospital up to 8 times over a 13
month period.
Status | Completed |
Enrollment | 80 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - aged 18 years or over - end stage renal disease (CKD stage 5 eGFR <15ml/min /1.73m2) - been on haemodialysis for at least 3 months. Exclusion Criteria: - Known heart failure - Left Ventricular Ejection Fraction <45%, - active gout - severe hepatic disease - or on azathioprine, 6 mercaptopurine, theophylline. - malignancy or other life threatening diseases, - pregnant or lactating women - any contraindication to MRI (claustrophobia, metal implants). - with a planned (relative) kidney transplant, - Patients who have participated in any other clinical trial within the previous 30 days will be excluded. - Patients who are unable to give informed consent will also be excluded from this trial. - Any other considered by a study physician to be inappropriate for inclusion |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | NHS Ayrshire and Arran | Crosshouse | |
United Kingdom | NHS Tayside | Dundee | Tayside |
United Kingdom | NHS Greater Glasgow and Clyde | Glasgow | La |
Lead Sponsor | Collaborator |
---|---|
University of Dundee | British Heart Foundation, NHS Greater Glasgow and Clyde, NHS Tayside, University of Glasgow |
United Kingdom,
Kao MP, Ang DS, Gandy SJ, Nadir MA, Houston JG, Lang CC, Struthers AD. Allopurinol benefits left ventricular mass and endothelial dysfunction in chronic kidney disease. J Am Soc Nephrol. 2011 Jul;22(7):1382-9. doi: 10.1681/ASN.2010111185. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome is to measure if allopurinol, induces a change in Left ventricular Mass Index in patients with ESRD when compared to placebo. | following 1 year of therapy | No | |
Secondary | To decide on optimum dosing regime of allopurinol in End Stage Renal Disease from pilot study | The dose of allopurinol required to reduce urate levels by 41% will be determined. | 6 weeks | No |
Secondary | To measure any difference in endothelial function with allopurinol compared with placebo, measured by Flow Mediated Dilatation and Pulse Wave Analysis | following 1 year of therapy | No | |
Secondary | To assess if the incidence of adverse events differs on allopurinol compared to placebo in patients with end stage renal disease | during course of 1 year of therapy | Yes | |
Secondary | To measure any change in LV end systolic volume, LV end diastolic volume or LV ejection factor with allopurinol in ESRD patients compared with placebo. | Following 1 year of therapy | No | |
Secondary | To measure changes in inflammatory blood markers, in ESRD with allopurinol compared with placebo. | Following 1 year of therapy | No | |
Secondary | To measure changes in BP control as measured by clinic BP and 24hr BP monitoring with allopurinol compared with placebo | Following 1 year of therapy | No |
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