Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency
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|ClinicalTrials.gov Identifier: NCT02147782|
Recruitment Status : Recruiting
First Posted : May 28, 2014
Last Update Posted : April 18, 2018
|Condition or disease|
|Chronic Renal Insufficiency Renal Osteodystrophy|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Continuous Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency in Different Stages|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||December 2019|
Healthy people from physical examination centers are recruited as controls.
with clinical symptoms and signs of kidney injury, and 60<=GFR<=89（ml/min/1.73m²)
with clinical symptoms and signs of kidney injury, and 30<=GFR<=59（ml/min/1.73m²)
with clinical symptoms and signs of kidney injury, and 15<=GFR<=29（ml/min/1.73m²)
with clinical symptoms and signs of kidney injury, and GFR<15（ml/min/1.73m²)
- bone metabolism (bone mineral density and serum bone turnover biomarkers) [ Time Frame: 1 day after enrollment ]lumbar (L1-4 as well as total) and hip (neck, troch, inter and word's) bone mineral density will be recorded by dual energy X-ray absorptiometry. Serum bone turnover biomarkers including total PINP, BGP, BALP and β-CTx will be detected.
- Kidney function （blood creatinine and urea nitrogen,glomerular filtration rate） [ Time Frame: 1 day after enrollment ]CKD1-5 will be graded by glomerular filtration rate,and blood creatinine and urea nitrogen will be detected.
- Calcium and phosphorus metabolism (serum calcium and phosphorus,calcium-phosphorus product, FGF23, PTH and 25-OH-VitD) [ Time Frame: 1 day after enrollment ]Serum calcium and phosphorus will be detected and the calcium-phosphorus product will be calculated.Factors which are related with calcium and phosphorus including FGF23, PTH and 25-OH-VitD will be detected.
- MicroRNA array [ Time Frame: 1 day after enrollment ]Blood plasma will be collected for microRNA array analysis to find specific biomarkers for each stage.We will also try to find biomarkers for better definitions of chronic renal insufficiency and renal osteodystrophy.
- Baseline information （height, weight, sex） [ Time Frame: 1 day after enrollment ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147782
|Contact: Yongjun Wang, MD,PhDfirstname.lastname@example.org|
|Contact: Bing Shu, PhDemail@example.com|
|Anhui Province Hospital of TCM||Recruiting|
|Hefei, Anhui, China, 230031|
|Contact: Shunjin Hu 0551-62838661|
|Principal Investigator: Shunjin Hu|
|Jiangsu Province Hospital of TCM||Suspended|
|Nanjing, Jiangsu, China|
|Longhua hospital affiliated to Shanghai University of TCM||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Xiaofeng Li, PhD 86-21-64395700 firstname.lastname@example.org|
|Principal Investigator: Xiaofeng Li|
|Huadong Hospital Affiliated to Fudan University||Completed|
|Shanghai, Shanghai, China, 200040|
|Principal Investigator:||Yongjun Wang, Doctor||Shanhgai University of TCM|