UMIN ID: UMIN000001589
Registered date:19/12/2008
Observational Study on Cerebro- and Cardio-vascular Complication in Predialysis, Hemodialysis, and Peritoneal Dialysis Patients with Chronic Kidney Disease
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Chronic kidney disease |
| Date of first enrollment | 2008/12/01 |
| Target sample size | 300 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | 1. Alteration of brain volume in MRI 2. Alteration of calcification score in coronary CT |
|---|---|
| Secondary Outcome | 1. Incidence rate of overt cerebro- and cardio-vascular complications 2. Intima-media thickness of common carotid artery 3. Cardiac function examined by echocardiography and cine-MRI 4. Pulse wave velocity examined by MRI 5. Augmentation Index (AI) 6. Bone mineral density examined by dual-energy X-ray absorptiometry 7. Residual renal function 8. Higher brain function quantified using Japan Stroke Scale Higher Cortical Function (JSS-H) 9. Quality of life quantified using the Kidney Disease Quality of Life Short Form (KDQOL-SF) |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Pregnant women, or women who have a possibility of pregnancy 2. Patients using acidic dialysate 3. Patients who have previously received another dialysis therapy for over 3 months 4. Patients who have previously undergone renal transplantation |
Related Information
| Primary Sponsor | Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hisako Yoshida |
| Address | 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582 Japan |
| Telephone | 092-642-5843 |
| hisako@kcu.med.kyushu-u.ac.jp | |
| Affiliation | Graduate School of Medical Sciences, Kyushu University Department of Integrated Therapy for Chronic Kidney Disease |
| scientific contact | |
| Name | Kazuhiko Tsuruya |
| Address | Maidashi 3-1-1, Higashi-ku, Fukuoka Japan |
| Telephone | 092-642-5843 |
| tsuruya@intmed2.med.kyushu-u.ac.jp | |
| Affiliation | Graduate School of Medical Sciences, Kyushu University Department of Integrated Therapy for Chronic Kidney Disease |