Renal failure and left ventricular hypertrophy
Conditions
Interventions
Product Name: Allopurinol
Product Code: n/a
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ALLOPURINOL
CAS Number: 315-30-0
Concentration unit: mg milligram(s)
Concentration type: range
Conce
Sponsors
University of Dundee/NHS Tayside
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • are aged 18 to 80 years • end stage renal disease (CKD stage 5 eGFR 95g/m2 for women. • All concomitant medication will be allowed and continued unchanged unless clinically indicated during the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: • Known heart failure • Left Ventricular Ejection Fraction <45%, • already had gout or on allopurinol, • severe hepatic disease • or on azathioprine, 6 mercaptopurine, theophylline or warfarin. • malignancy or other life threatening diseases, • pregnant or lactating women • any contraindication to MRI (claustrophobia, metal implants). • with a planned (relative) kidney transplant, • Aged less than 18 or over 80 years • Above ankle amputees • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is split into two phases. Phase 1: is a dose finding study. The objective here is to find the minumum dose of allopurinol that will give an average 41% reduction in blood urate levels Phase 2 is the Main Trial. The primary objective here will be to see if Allopurinol can reverse harmful thickening of the heart muscle wall in patients undergoing dialysis. ;Secondary Objective: • To determine if there is a change in the efficiency of the hearts pumping capacity with allopurinol in dialysis patients compared with placebo. •To determine if there is a difference in how healthy the blood vessels are with allopurinol compared with placebo in patients with ESRD •To determine if there are changes in blood tests which indicate inflammation in ESRD with allopurinol compared with placebo. •To assess, if there are changes in Blood pressure control with allopurinol compared with placebo ;Primary end point(s): The primary outcome of the pilot study is to determine the minimum dose of allopurinol to induce an average 41% decrease in serum urate levels. The primary outcome in the main trial is to determine if allopurinol, induces a change in Left ventricular Mass Index in patients with ESRD when compared to placebo.;Timepoint(s) of evaluation of this end point: For the pilot study this can be 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weks or 6 weeks . For the main trial primary outcome is at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To determine if there is a change in LV end systolic volume, LV end diastolic volume or LV ejection factor with allopurinol in ESRD patients compared with placebo. 2. To determine if there is a difference endothelial function with allopurinol compared with placebo, measured by FMD and PWA 3. To determine if there are changes in inflammatory blood markers, in ESRD with allopurinol compared with placebo. 4. To assess, if there are changes in BP control as measured by clinic BP and 24hr BP monitoring with allopurinol compared with placebo ;Timepoint(s) of evaluation of this end point: 1- 12 months 2- 9 months and 12 months 3- 6 months,9 months, 12 months 4- 12 months | — |
Countries
United Kingdom
Contacts
Public ContactSteve McSwiggan
Tayside Clinical Trials Unit
Outcome results
None listed