Abstract
Objective: With limited data available on calcification prevalence in chronic kidney disease (CKD) patients on dialysis, the China Dialysis Calcification Study (CDCS) determined the prevalence of vascular/valvular calcification (VC) and association of risk factors in Chinese patients with prevalent hemodialysis (HD) or peritoneal dialysis (PD).
Methods: CKD patients undergoing HD/PD for ≥6 months were enrolled. Prevalence data for calcification and medical history were documented at baseline. Coronary artery calcification (CAC) was assessed by electron beam or multi-slice computed tomography (EBCT/MSCT), abdominal aortic calcification (AAC) by lateral lumbar radiography, and cardiac valvular calcification (ValvC) by echocardiography. Serum phosphorus, calcium, intact parathyroid hormone (iPTH), and 25-hydroxyvitamin D and FGF-23 were evaluated. A logistic regression model was used to evaluate the association between risk factors and VC.
Results: Of 1,497 patients, 1,493 (78.3% HD, 21.7% PD) had ≥1 baseline calcification image (final analysis cohort, FAC) and 1,423 (78.8% HD, 21.2% PD) had baseline calcification data complete (BCDC). Prevalence of VC was 77.4% in FAC (80.8% HD, 65.1% PD, p < .001) and 77.5% in BCDC (80.7% HD, 65.8% PD). The proportion of BCDC patients with single-site calcification were 20% for CAC, 4.3% for AAC, and 4.3% for cardiac valvular calcification (ValvC), respectively. Double site calcifications were 23.4% for CAC and AAC, 6.5% for CAC and ValvC, and 1.1% for AAC and ValvC, respectively. In total, 17.9% patients had calcification at all three sites.
Conclusions: High prevalence of total VC in Chinese CKD patients will supplement current knowledge, which is mostly limited, contributing in creating awareness and optimizing VC management.
Transparency
Declaration of funding
The CDCS, Chinese Clinical Trial Registry ChiCTR-OCH-1400447, is being sponsored by Sanofi (China) (DIREGL06764). The National Key Technology R&D Program (2013BAI09B04, 2015BAI12B05) also provides support to investigators of the study.
Declaration of financial/other relationships
All authors declare that they have received Sanofi research funds supporting CDCS. Peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no other relevant financial relationships to disclose.
Acknowledgments
Medical writing support under authors’ direction was provided by Priyanka Bannikoppa, PhD, Karan Sharma, M.Pharm (Indegene Pvt. Ltd., Bangalore), and Kim Coleman Healy, PhD, CMPP (Envision Scientific Solutions), as funded by Sanofi China. The authors acknowledge additional principal investigators Dr Jian-Zhong Meng (retired) Jinan Military General Hospital, Dr Wei Shi, Guangdong General Hospital, and study biostatistician Lichuang Men of Sanofi China. Also, Dr Hai-Tao Zhang from the National Clinical Research Center of Kidney Disease, Jinling Hospital, Nanjing University School of Medicine and Dr Xi Zhang from Sanofi China contributed to study design, data analysis and review or interpretation.
Institutional Ethics Committees (IECs) approval
Ethics Committee of Jinling Hospital, Nanjing University School of Medicine; IEC for Clinical Research of Zhongda Hospital, Affiliated to Southeast University; IEC for Clinical Research of Jiangsu Province Hospital (The First Affiliated Hospital With Nanjing Medical University); IEC for Clinical Research of The Second Affiliated Hospital With Nanjing Medical University; IEC for Clinical Research of Nanjing First Hospital (The Affiliated Nanjing Hospital With Nanjing Medical University; Ethics Committee of Huashan Hospital; The Ethics Committee of Peking University People's Hospital; The Clinical Research Ethics Committee of Peking University First Hospital; The Clinical Research Ethics Committee of Beijing Anzhen Hospital; Ethic Committee of Peking University Third Hospital; Ethic Committee of the Second Hospital of Tianjin Medical University; Ethic Committee of Jinan Military General Hospital; Ethic Committee of Shandong Provincial Hospital; The First Affiliated Hospital, Sun Yat-sen University Research Ethics Committee; Guangdong General Hospital Research Ethics Committee; Nanfang Hospital Research Ethics Committee; Guangzhou First People’s Hospital Ethics Committee; Medical Ethics Committee of Centre-South University; Medical Ethics Committee of Sichuan Provincial People’s Hospital; Shanghai Tongji Hospital Ethics Committee; The Ethics Committee of Shanghai Tenth People's Hospital; The Ethics Committee of Zhongshan Hospital Xiamen University.
Prior presentations
Part of these results were presented at the 53rd European Renal Association-European Dialysis Treatment Association Congress, Vienna, Austria, May 21–24, 2016.