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Children with Down syndrome's renal function formula study

Down syndrome's estimate Glomerular Filtration Rate formula study - DeGFR study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038673
Enrollment
30
Registered
2019-12-01
Start date
2019-12-01
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

Down syndrome eGFR&lt

Interventions

All children are hospitalized for 2 days and examined. The same person is not measured repeatedly only once for each subject. The amount of drugs and fluid replacement is calculated based on the weig
s solution load of 20 ml/kg body weight for 30 min to obtain good diuresis, following by a load of 5 ml/kg/h until testing completion. From 30 min after water loading, inulin give intravenously in a p
s formula. Therefore, the patients received an inulin load of 0.7 * eGFR ml/m2/h with calculation of body surface area by the Haycock method. We collect Urine samples in two periods of 1 h each, and b

Sponsors

Division of Nephrology, Saitama Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Meets all of the following Down syndrome 2 to 18 years old eGFR<90 ml/min/1.73m2: Uemura's formula

Exclusion criteria

Exclusion criteria: Any one of the following congenital anomalies of the kidney and urinary tract chronic glomerulonephritis Respiratory or heart failure requiring oxygen administration Under treatment for gastrointestinal symptoms and infectious diseases, inflammatory diseases Women who are pregnant or may be pregnant neuromuscular disease, muscle disease Mental disorders Immune disorder malformation syndrome other than Down syndrome Abnormal separate quantitative renal function (more than 20% left-right difference) In this study, which the ratios of urine inulin excretion and intravenous inulin administration were <0.5 or >1.5 In this study, glomerular filtration rate >150 ml/min/1.73m2

Design outcomes

Primary

MeasureTime frame
inulin clearance Blood test: creatinine, inulin Before test start, 30 minutes after start, 90 minutes later Urinalysis: creatinine, inulin Before test start, at start, after 60 minutes, after 120 minutes

Secondary

MeasureTime frame
Gender, age, height, complications Blood test: Cystatin C, B2MG Urinalysis: B2MG separate quantitative renal function: 99mTc-DMSA Congenital anomalies of the kidney and urinary tract: Abdominal ultrasonography Comparison with eGFR obtained from Uemura's formula

Countries

Japan

Contacts

Public ContactTomohiko Nishino

Saitama Children's Medical Center Division of Nephrology

sinonosino@yahoo.co.jp048-601-2200

Outcome results

None listed

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