Insights in proximal and distal tubular iron reabsorption by studies on urinary iron excretion in human health and disease

Insights in proximal and distal tubular iron reabsorption by studies on urinary iron excretion in human health and disease - Renal iron reabsorption in human health and disease

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43424

Enrollment

Registered

2016-06-16

Start date

2016-07-25

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

ijzerstapelingsziekten Renal disease systemic iron overload

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers: age 18-80 years of age. Subjects with tubulopathy: age 18 - 80 years, diagnosed with tubulopathy by treating physician (e.g. Fanconi syndrome, Dent's disease, Wilson's disease, cystinosis, tubulo-interstitial nephritis (TIN) or suffers from tubulopathy secondary to e.g. multiple myeloma of secondary nephrogenic diabetes insipidus (sNDI)). This group also comprises subjects with tubulopathy and glomerulopathy: 18-80 years of age, proteinuria (EKR> 0.2 g/ 10 mmol creatinine), tubular dysfunction (urinary excretion of *1-microglobulin (>50 ug/min) and/or *2-microglobulin (>1 ug/min). Subjects with systemic iron overload: age 18-80 years of age, diagnosed with HFE-hereditary hemochromatosis, b-thalassemia major or intermedia, or Diamond Blackfan anemia by treating physician, with transferrin saturation (TSAT) > 70%.

Exclusion criteria

Exclusion criteria: Urinary tract infection, menstruating (female), use of iron chelation medication. Healthy volunteers will be excluded in case of a known history of renal diseases or systemic iron overload.

Design outcomes

Primary

Measure	Time frame
The main study parameters are the level of urinary iron parameters (total iron, transferrin, NTBI and LPI relative to urinary creatinine concentration) in all study groups.	—

Secondary

Measure	Time frame
The secundary study parameters are the level of blood iron parameters (total iron, transferrin, NTBI, LPI and ferritin), (e)GFR, CRP, urinary albumin concentration relative to urinary creatinine concentration, a panel of specific proximal and distal tubular dysfunction/injury markers (KIM-1, L-FABP, GST-a for proximal and H-FABP, GST-pi, for distal tubules, respectively) relative to urinary creatinine concentration and urinary pH.	—

Measure

Time frame

The secundary study parameters are the level of blood iron parameters (total iron, transferrin, NTBI, LPI and ferritin), (e)GFR, CRP, urinary albumin concentration relative to urinary creatinine concentration, a panel of specific proximal and distal tubular dysfunction/injury markers (KIM-1, L-FABP, GST-a for proximal and H-FABP, GST-pi, for distal tubules, respectively) relative to urinary creatinine concentration and urinary pH.

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Countries

Netherlands

Outcome results