drugset / Trial / NCT01447368
Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients
RandomizedParallel-groupSingle-blindTreatment
Summary
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.
Timeline
- Start
- 2010-05-10
- Primary completion
- 2017-05-22
- Completion
- 2017-05-22
Publications
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cinacalcet | Other / unclassified | 25 mg | Oral |