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A clinical study of KRN321 in pediatric patients

A clinical study of KRN321 in pediatric patients with chronic kidney disease

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221341
Enrollment
Unknown
Registered
2010-12-24
Start date
2010-12-24
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

Interventions

investigational material(s) Generic name etc : KRN321 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigation

Sponsors

Kyowa Hakko Kirin Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Written informed consent from guardian - ND patients (diagnosed with CKD and not receiving hemodialysis), PD patients (receiving peritoneal dialysis), or HD patients (receiving hemodialysis once a week or over)

Exclusion criteria

Exclusion criteria: - Uncontrolled hypertension - Congestive heart failure - Malignant tumor, hematological disease or hemorrhagic lesion - Within 16 weeks preceding the study, excessive bleeding or blood transfusion associated with surgical operation etc. - Serious allergy (include drug hypersensitivity) - Hypersensitivity for rHuEPO agents

Design outcomes

Primary

MeasureTime frame
Efficacy (Hb level) Safety (Adverse events)—

Outcome results

None listed

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