PROCEED
Comparison of Medical Therapy (Oral Cinacalcet) Versus Surgical Therapy (Total Parathyroidectomy) on Vascular/Valvular Calcification in Chronic Peritoneal Dialysis Patients With Secondary Hyperparathyroidism - A Pilot Randomized Study
Sponsor study identifier
interventional
67
1 country
1
Study Start
May 10, 2010
Actual (reported)Primary Completion
May 22, 2017
Actual (reported)Study Completion
May 22, 2017
Actual (reported)This is a pilot, prospective randomized controlled study with the primary objective to evaluate and compare medical treatment of severe SHPT, namely oral cinacalcet versus surgical treatment, that is, parathyroidectomy with forearm autografting, on the progression of coronary artery and valvular calcification and left ventricular mass index in endstage renal disease patients receiving peritoneal dialysis over 12 months. The change in arterial stiffening, left ventricular volume, aortic valve calcium score and bone mineral density, nutritional status and biochemical parameters, quality of life measures will be evaluated as secondary objectives of this study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 22, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 10, 2010
Actual (reported)October 4, 2011
Actual (reported)October 6, 2011
Actual (reported)May 22, 2017
Actual (reported)May 22, 2017
Actual (reported)Change in coronary artery calcium score
Change in coronary artery calcium score
52 weeks
change in left ventricular mass index
change in left ventricular mass index
52 weeks
change in left ventricular volume and ejection fraction
52 weeks
Oral Cinacalcet treatment arm, 25mg daily to be administered and gradually step up as required to control iPTH between 2 - 9 times lab reference range, Maximum dose to be given is 100mg daily
Surgical total parathyroidectomy with forearm autografting will be performed for patients randomized to this arm.
oral cinacalcet 25mg once daily as a start and up titrated by 25mg daily according to response in lowering PTH and maximum oral dose allowed is 100mg daily
Surgical total parathyroidectomy with forearm autografting will be performed
Queen Mary Hospital and Tung Wah Hospital
Hong Kong, 0000, Hong Kong
Wang AY, Tang TK, Yau YY, Lo WK. Impact of Parathyroidectomy Versus Oral Cinacalcet on Bone Mineral Density in Patients on Peritoneal Dialysis With Advanced Secondary Hyperparathyroidism: The PROCEED Pilot Randomized Trial. Am J Kidney Dis. 2024 Apr;83(4):456-466.e1. doi: 10.1053/j.ajkd.2023.10.007. Epub 2023 Nov 30.
Wang AY, Lo WK, Cheung SC, Tang TK, Yau YY, Lang BH. Parathyroidectomy versus oral cinacalcet on cardiovascular parameters in peritoneal dialysis patients with advanced secondary hyperparathyroidism (PROCEED): a randomized trial. Nephrol Dial Transplant. 2023 Jul 31;38(8):1823-1835. doi: 10.1093/ndt/gfad043.
Angela YM Wang, MD, PhD
University of Hong Kong, Queen Mary Hospital
67 participants (actual enrollment reported by the registry).
First Submitted
October 4, 2011
First Posted
October 6, 2011
Study Start
May 10, 2010
Change in aortic pulse wave velocity
24 and 52 weeks
Change in aortic valve and mitral valve calcium score
52 weeks
change in augmentation index and heart rate adjusted augmentation index
over 52 weeks
change in bone mineral density at forearm, spine and femur
52 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
May 22, 2017
Actual (reported)Study Completion
May 22, 2017
Actual (reported)Last Updated
October 12, 2021
Record last verified: 2021-10
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Source: ClinicalTrials.gov.
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