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Cross-over study of PDLYMT in chronic kidney disease (CKD) patients undergoing hemodialysis therapy

Cross-over study of PDLYMT in chronic kidney disease (CKD) patients undergoing hemodialysis therapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080225039
Enrollment
52
Registered
2020-01-24
Start date
2020-04-13
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

CKD patients undergoing hemodialysis therapy

Interventions

investigational material(s) Generic name etc : PDLYMT INN of investigational material : - Therapeutic category code : 341 Agents for artificial kidney dialysis Dosage and Administration for Investigat

Sponsors

NIPRO CORPORATION
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients providing written informed consent about participation in this clinical study - Patients aged 20 to 84 years old at the time of informed consent , etc.

Exclusion criteria

Exclusion criteria: - Patients within 3 months of initiating hemodialysis at the time of informed consent - Patients who find it difficult to undergo HD stably during the entire duration of this study - Patients who are pregnant or who have the possibility of pregnancy at the time of informed consent - Patients participating in clinical studies of other drugs, medical devices, etc. at the time of informed consent for this study - Patients who may not be able to be evaluated as described in the protocol due to serious disease - Patients judged by the investigator or sub-investigator to be inadequate for this study , etc.

Design outcomes

Primary

MeasureTime frame
efficacy confirmatory [Efficacy] Reduction ratio

Secondary

MeasureTime frame
safety efficacy confirmatory [Efficacy] Correction of serum electrolytes and blood acid-base balance, etc. [Safety] Adverse event, etc.

Countries

Japan

Outcome results

None listed

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