The effect of intervention with darbepoetin alfa on progression of renal decline[chronic renal failure?] in renal anaemia patients with chronic kidney disease not on dialysis.

The effect of intervention with darbepoetin alfa on progression of renal decline[chronic renal failure?] in renal anaemia patients with chronic kidney disease not on dialysis. - Renal function is sustained by renal anemia inprovement using Nesp.- Juntendo (REFRAIN -J study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006963

Enrollment

200

Registered

2011-12-27

Start date

2011-07-01

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 anaemia patients with chronic kidney disease not on dialysis

Interventions

Darbepoetin alfa is administered to renal anaemia patients with chronic kidney disease not on dialysis and it maintains it to Hb value 11g/dL or more.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Patients with chronic kidney disease not on dialysis.[Non-dialysis CKD patients] *Patients with renal anemia, their levels of Hb are less than 11g/dL *20 years of age and older

Exclusion criteria

Exclusion criteria: *Patient without renal anemia *Patient having hypersensitivity to rHuEPO. *Level of Hb is more than 13g/dL *Patients with anemia caused by conditions other than renal anemia such as GI bleeding and blood desease *Patients with serious allergies or serious drug sensitivities *Patients with severe complications *Pregnant or possibly pregnant and lactaing women *Ineligible patients according to the investigator's judgment

Design outcomes

Primary

Measure	Time frame
Change in kidney function after two years (The changes in renal function after darbepoetin alfa treatment)	—

Secondary

Measure	Time frame
1.Changes of biochemical makers in sera 2.Stratification comparison by inspection items (level of Hb and eGFR) **Stratified analyses using baseline Hb level and doses of darbepoetin alfa	—

Countries

Japan

Contacts

Public ContactChieko Hamada

Department of Internal Medicine,juntendo University Faculty of Medicine Division of Nephrology

chieko@juntendo.ac.jp03-5802-1065

Outcome results

None listed

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