Effect of darbepoetin alfa on quality of life in anemia of chronic kidney disease elderly patients with type 2 diabetes mellitus

Effect of darbepoetin alfa on quality of life in anemia of chronic kidney disease elderly patients with type 2 diabetes mellitus - Effect of darbepoetin alfa for on diabetic elderly patients with renal anemia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007693

Enrollment

Registered

2012-04-09

Start date

2012-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal anemia with type 2 diabetes mellitus

Interventions

Darbepoetin alfa is administered to renal anemia patients with chronic kidney disease not on dialysis and it maintains it to Hb value 12g/dL around

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with type 2 diabetes on glycemic control stability during 3 months 2) Patients with chronic kidney disease not on dialysis 3) Patients with renal anaemia on level of Hb is less than 10g/dL 4) Age >=65years 5) A consent form for participating in this study is submitted

Exclusion criteria

Exclusion criteria: 1) Patients with cognitive impairment and on the anti cognitive impairment drug 2) Patients with impossible control of hypertension 3) Patients with impossible glycemic control 4) Patients with congestive heart failure 5) Patients with major surgery within 16 weeks 6) Patients with red blood cell (RBC) transfusions within 16 weeks 7) Patients receiving anabolic steroid hormone, testosterone enanthate, mepitiostane within 16 weeks 8) Patients with anemia caused by conditions other than renal anemia such as GI bleeding and blood desease 9) Patients with history of stroke, MI or other sever vascular complication which required a hospitalization 10) Patients with serious allergies or serious drug sensitivities 11) Patients with serious liver dysfunction (ALT or AST greater than 2 times the upper limit of hpspital standard) 12) Patients with scheduled to receive a renal replacement therapy 13) Patients having hypersensitivity to rHuEPO 14) Other patients determined to be inappropriate by physician

Design outcomes

Primary

Measure	Time frame
Amount of changes QOL(SF-36) from the baseline to 3 months later after darbepoetin alfa treatment.	—

Secondary

Measure	Time frame
1)Changes of QOL(SF-36) from the beseline to 3 and 6 months later 2)Changes of ADL(Barthel Index) from the beseline to 3 and 6 months later 3)Changes of MMSE and GDS15 from the beseline to 3 and 6 months 4)Changes of NTpro-BNP from the beseline to 3 and 6 months later 5)Changes of L-FABP and Ucr from the beseline to 3 and 6 months later 6)Changes of MDL-LDL from the beseline to 3 and 6 months later 7)Changes of HOMA-IR and Ucr from the beseline to 3 and 6 months later 8)Proportion of subjects on maintained with a target Hb 11-13 g/dL during 6 months	—

Measure

Time frame

1)Changes of QOL(SF-36) from the beseline to 3 and 6 months later 2)Changes of ADL(Barthel Index) from the beseline to 3 and 6 months later 3)Changes of MMSE and GDS15 from the beseline to 3 and 6 months 4)Changes of NTpro-BNP from the beseline to 3 and 6 months later 5)Changes of L-FABP and Ucr from the beseline to 3 and 6 months later 6)Changes of MDL-LDL from the beseline to 3 and 6 months later 7)Changes of HOMA-IR and Ucr from the beseline to 3 and 6 months later 8)Proportion of subjects on maintained with a target Hb 11-13 g/dL during 6 months

—

Countries

Japan

Contacts

Public ContactKazuki Kobayashi

Graduate School of Medicine, Chiba University Clinical Cell Biology and Medicine

koba-chi@faculty.chiba-u.jp043-226-2092

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026