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Phosphate Reduction Or Supplementation Intervention Trial

Phosphate Reduction Or Supplementation Intervention Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27814
Enrollment
42
Registered
2015-11-17
Start date
2016-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Chronic Kidney Disease (chronische nierinsufficiëntie)

Interventions

Low phosphate diet combined with phosphate supplement or placebo

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • CKD • Estimated GFR >30 mL /min/1.73 m2 • Residual albuminuria ≥ 500 mg /day despite treatment with optimally dosed ACEi or ARB. • Age ≥ 18 years

Exclusion criteria

Exclusion criteria: • Current use of phosphate binder therapy • Hyperphosphatemia >2.00 mmol/L • Hypocalcaemia (corrected serum calcium 2.60 mmol/L) • Hyperkalemia (serum potassium >5.50 mmol/L) • Blood pressure >180/100 mmHg after study run-in period. • Chronic diarrhea (>5 diarrhea stools/day for >2 weeks • Chronic inflammatory bowel disease • Chronic NSAID use • Diabetes Mellitus • Non-glomerular source of proteinuria • Contraindications to ACEi therapy or high/low phosphate intake • Unstable disease (at the discretion of the nephrologist, such as persistent renal function loss > 6 mL/min/1.73m2 per year, not explainable by intercurrent events, with accompanying changes in serum creatinine and urea).

Design outcomes

Primary

MeasureTime frame
Residual albuminuria (24h urine collection)

Secondary

MeasureTime frame
C-terminal FGF23 levels, 24-hourly phosphorus excretion, serum phosphate levels, serum calcium levels, 24-hourly calcium excretion, residual proteinuria, systolic blood pressure, Serum calcification propensity

Contacts

Public ContactM.A. de Jong

Universitair Medisch Centrum Groningen - Afdeling Nefrologie, HPC AA53

M.A.deJong03@umcg.nlPhone +31 50 3615119

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)