NCT02226055|Completed
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Sponsor study identifier
observational
200
1 country
1
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 1, 2017
Actual (reported)Study Completion
May 1, 2017
Actual (reported)Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 25, 2014
Actual (reported)August 26, 2014
Actual (reported)September 2014
Date type not reportedThis date has not been verified as actual or estimated.
May 1, 2017
Actual (reported)May 1, 2017
Actual (reported)Arterial stiffness
Arterial stiffness will be measured using the TensioMed® Arteriograph™. Damage to large arteries contributes to increased cardiovascular risk in CKD. Atherosclerosis is the most frequent cause of arterial damage but medial calcification seen in CKD also leads to arterial stiffening. This stiffening causes elevated systolic blood pressure, increased left ventricular workload and the gradual development of LVH, and also a fall in diastolic blood pressure impairing coronary blood flow. Arterial calcification and stiffness are independent predictors of all-cause and cardiovascular mortality in CKD patients. It is unclear whether the CVD risk associated with CKDu is the same as it is for CKD of known cause. We plan to measure arterial stiffness in both CKD and CKDu patients. We will compare stiffness measurements in CKD of unknown cause with those of a well characterised cohort of CKD patients in Edinburgh. Healthy Sri Lankan volunteers will give an assessment of 'background stiffness'.
3 months
Biomarkers of renal disease and DNA adducts
3 months
Cohort of 50 patients with CKD of unknown aetiology Inclusion and exclusion criteria below Measure of arterial stiffness using pulse wave velocity technology Assessment of BMI, central and brachial blood pressure, arterial stiffness and 'arterial age' will be made and fed back to the patient. this information will be given in a 'results sheet' that the participant will be encouraged to give to their Gp for further treatments required.
Cohort of 50 patients with CKD of known cause Inclusion and exclusion criteria below Measure of arterial stiffness using pulse wave velocity technology Assessment of BMI, central and brachial blood pressure, arterial stiffness and 'arterial age' will be made and fed back to the patient. this information will be given in a 'results sheet' that the participant will be encouraged to give to their Gp for further treatments required.
Cohort of 50 participants who are healthy Sri Lankan volunteers Inclusion and exclusion criteria below Measure of arterial stiffness using pulse wave velocity technology Assessment of BMI, central and brachial blood pressure, arterial stiffness and 'arterial age' will be made and fed back to the patient. this information will be given in a 'results sheet' that the participant will be encouraged to give to their Gp for further treatments required.
The following will be measured: brachial systolic and diastolic bp, heart rate, mean arterial bp, pulse pressure, brachial augmentation index (difference between the amplitudes of the late (backward) systolic wave (P2) and the early (forward) systolic wave (P1) over the pulse pressure x 100), central augmentation, ejection duration of the left ventricle, return time (time of the pulse wave travelling from aortic root to the bifurcation and back), aortic pulse wave velocity ( velocity of the pulse wave in the aorta), central systolic bp, central pulse pressure and diastolic reflection area (provides information about the quality of diastolic filling in the coronary arteries). We will perform an arterial age assessment. Patients are given a feedback form with their results to give to their general. Those with increased arterial stiffness will be tested for serum calcium and phosphate levels, and audited to ensure that a statin is commenced if not contraindicated.
Patients attending clinics or admitted to hospital during Aug 2014 to Oct 2014 with CKDu (Chronic kidney disease of unknown origin). Subjects must be aged 18 to 85 with evidence of renal dysfunction and no other obvious cause noted (see inclusion/exclusion criteria above). Control groups will be sought for the measure of arterial stiffness: Sri Lankan CKD of known cause, Sri Lankan healthy volunteers. Our controls will be age, sex and blood pressure matched to the cases.
Teaching Hospital Anuradhapura
Anuradhapura, North Central Province, A13, Sri Lanka
Urine samples: up to 30ml Blood samples: up to 40ml - 2 x EDTA blood bottles + 2 x serum gel Z bottles
Michael Eddleston, MA PhD FRCPEdin
University of Edinburgh
Neeraj Dhaun, PhD MRCP
University of Edinburgh
Sisira Siribaddana, MD FCCP
Rajarata University, Sri Lanka
200 participants (actual enrollment reported by the registry).
First Submitted
August 25, 2014
First Posted
August 26, 2014
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients
To recruit a cohort of up to 250 CKDu patients from specific CKDu clinics in Anuradhapura and Padavi-Sri Pura for detailed history, basic anthropometric tests, and further analysis of serum, and urine. Analysis for biomarkers of kidney damage, proteomics, exosomes, and DNA adducts will be used to seek information that may complement already collected data and help refine aetiological hypotheses. Inclusion and Exclusion criteria as per CKDu cases in cohort 1
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Primary Completion
May 1, 2017
Actual (reported)Study Completion
May 1, 2017
Actual (reported)Last Updated
November 1, 2017
Record last verified: 2017-10
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