UMIN ID: UMIN000001285
Registered date:07/08/2008
A prospective multicenter study of Vitamin E bonded polysulfone membrane for Erythropoiesis Stimulation Agents in Hemodialysis Patients
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | end-stage renal disease hemodialysis patients with renal anemia |
| Date of first enrollment | 2008/08/01 |
| Target sample size | 300 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Object group : with vitamin E bonded polysulfone membrane dialyzer (VPS-HA), Hb range is matched 10 to 11 g/dL as Hb at the initial point. Control group : with type 4 polysulfone membrane dialyzer, Hb range is matched 10 to 11 g/dL as Hb at the initial point. Object group : with vitamin E bonded polysulfone membrane dialyzer (VPS-HA), Hb range is matched 11 to 12 g/dL as Hb at the initial point. Control group : with type 4 polysulfone membrane dialyzer, Hb range is matched 11 to 12 g/dL as Hb at the initial point. |
Outcome(s)
| Primary Outcome | To observasion of dosage for erythropoiesis stimulation agents which is need to maintain Hb at the initial point with vitamin E bonded dialyzer:VPS-HA. |
|---|---|
| Secondary Outcome | peripheral blood general tests (hemoglobin, hematocrit, red blood cell counts, white blood cell counts, platelets counts), reticulocyte counts, serum iron, serum ferritin, serum transferrin, serum total iron binding capacity (TIBC), indirect bilirubin, serum high sensitive CRP, red blood cell distribution width, the dosage of iron medicine, a species / dosage of the antihypertensive agent, the dialysate endotoxin value. In addition, the event of the cardiovascular diseases by accumulation in two years. |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | The hemodialysis patient with normal polycystic kidney disease. In addition, the incompetent patient who was rejected by a doctor. |
Related Information
| Primary Sponsor | The Society of Vitamembrane |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Asahikasei Kuraray Medical Co., LTD. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | MASAHIDE KOREMOTO |
| Address | 1-105 Kanda Jinbocho, Chiyoda-ku, Tokyo 101-8101, Japan Japan |
| Telephone | 03-3296-3723 |
| m-koremoto@umin.ac.jp | |
| Affiliation | The Society of Vitamembrane Secretariat Scientific and Technical Affairs Department, Dialysis Products Division, Asahikasei Kuraray Medical |
| scientific contact | |
| Name | TAKAHIRO MOCHIZUKI |
| Address | 929 Higashi-cho, Kamogawa City, Chiba Prefecture, 296-8602, Japan Japan |
| Telephone | 04-7092-2211 |
| Affiliation | Kameda Medical Center Nephrology |