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Phosphor study

The effect of PHOSPHate control On Renal function in chronic kidney disease patients not on dialysis-PHOSPHOR study - The effect of PHOSPHate control On Renal function in chronic kidney disease patients not on dialysis-PHOSPHOR study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041180179
Enrollment
160
Registered
2019-03-29
Start date
2018-03-27
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Hyperphosphatemia

Interventions

Blood sampling Administration of ferric citrate hydrate

Sponsors

Shigeru Shibata
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients in adults (over 20 years old) 2)No gender 3)Patients with eGFR (mL / min / 1.73 m 2) calculated from the serum creatinine value of 15 or more and less than 45 and serum phosphorus value of 4.0 mg / dL or more (including patients taking phosphorus adsorbent) 4)Patients whose eGFR (mL / min / 1.73 m 2) calculated from the serum creatinine value is 15 or more and less than 45 and serum phosphorus value is 4.0 mg / dL or more (patients who are taking phosphorus adsorption drugs have no acute renal function change, CKDPatients whose systemic condition is stable as treatment intervention other than administration of phosphorus adsorption is performed according to clinical guide (edited by Japan Society of Nephrology) 5)Patients receiving one or more appropriate nutritional guidance 6)Patients who agreed to participate in the study

Exclusion criteria

Exclusion criteria: 1)Patients contraindicated for administration of ferric citrate hydrate 2)Patients with a history of hypersensitivity to the ingredients of this drug 3)Patients with iron overload such as hemochromatosis 4)Defective diabetes (HbA1c> 9.0%) 5)Uncontrolled hypertension (systolic blood pressure of 170 mmHg or more or diastolic blood pressure of 110 mmHg or more) 6)Acute renal failure, nephrotic syndrome, people who have undergone hemodialysis after kidney transplantation 7)tumor (no recurrence, do not exclude those who are untreated for 5 years) 8)Those who are pregnant, lactating, planning pregnancy during the study 9)Persons who are undergoing or are undergoing hormone therapy (HRT) with estrogen 10)Patient using Cinacalcet (Regala R) 11)Patients who are judged inappropriate by the attending physician (dementia, mental retardation, etc.)

Design outcomes

Primary

MeasureTime frame
Change from eGFR baseline

Secondary

MeasureTime frame
1)Duration up to 30% decline of eGFR 2)Serum phosphorus level 3)Urinary albumin amount (g / gCre), urinary phosphorus excretion 4)Blood calciprotein particles (CPP), urinary L-FABP 5)FGF23, intact PTH 6)Iron (Fe / TIBC, ferritin) 7)Anemia (Hb)

Contacts

Public Contactakiyama rumi

teikyo university

kohimeyo@yahoo.co.jp+81-3-3964-8073

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026