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Prospective Study of hyperphosphatemia in CKD5D patients undergoing hemodialysis (STOP-HD).

Prospective Study of hyperphosphatemia in CKD5D patients undergoing hemodialysis (STOP-HD). - STudy Of hyperPhosphatemia in CKD5D patients undergoing HemoDialysis (STOP-HD).

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002002
Enrollment
400
Registered
2009-05-25
Start date
2009-06-01
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

Hemodialysis patients with hyperphosphatemia

Interventions

Lanthanum carbonate 250-750mg will be administered orally three times daily after meals for 5 years.

Sponsors

Phosphate Research group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) CKD5D patients undergoing HemoDialysis, Age >=20 2) Patients who can receive La carbonate treatment 3) Patients who undergo hemodialysis between 3 months and 10 years 4) Possible long term observation patients 5) Patients with written IC (Informed Consent)

Exclusion criteria

Exclusion criteria: 1) Patients with cancer or suspicious for cancer 2) Pregnant or possibly pregnant patients, patients on lactation 3) Patients who meet the contraindiation criteria in package insert of Lanthanum carbonate 4) Inappropriate patients for this study according to the investigator's judgment

Design outcomes

Primary

MeasureTime frame
#Treatment status of phosphate binders and VitaminD #Measure aortic calcification (ACI) at baseline and after the treatment of La carbonate (maximum 5 years).

Secondary

MeasureTime frame
P,Ca, intact-PTH, Alb, Lipid, CRP, hepatic function, CTR, nPCR, vital sign, safety and tolerability at baseline and after the treatment of La carbonate (maximum 5 years).

Countries

Japan

Contacts

Public ContactAssociate Professor, Shigeo Negi

Wakayama Medical University Division of Nephrology & Blood Purification Medicine

shigeon@wakayama-med.ac.jp

Outcome results

None listed

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