Modulation of phosphate intake can affect the antiproteinuric efficacy of RAAS-blockade therapy in CKD patients
ID
Bron
Verkorte titel
Aandoening
Chronic Kidney Disease (chronische nierinsufficiëntie)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Residual albuminuria (24h urine collection)
Achtergrond van het onderzoek
Chronic Kidney Disease (CKD) is an important global health issue, affecting ~10% of the world population. Despite current state-of-the-art treatment, mainly pharmacological inhibition of the renin-angiotensin-aldosterone system (RAAS), renal function loss remains progressive in many patients. Recent observational studies suggest that factors involved in mineral metabolism, and the phosphaturic hormone fibroblast growth factor 23 (FGF23) in particular, may influence the renoprotective efficacy of RAAS-blockade. Circulating FGF23 levels increase in parallel with renal function loss and high levels of FGF23 are strongly associated with morbidity and mortality in patients with CKD. FGF23 levels can be reduced by limiting the intestinal uptake of phosphate. Based on these findings, we hypothesise that reducing phosphate intake in CKD patients could be an effective strategy to improve the response to RAAS-blockade. To test this hypothesis, we will conduct a randomised controlled, double blinded, cross-over intervention study.
Doel van het onderzoek
Modulation of phosphate intake can affect the antiproteinuric efficacy of RAAS-blockade therapy in CKD patients
Onderzoeksopzet
week 3 and 6 of each study period (cross-over)
Onderzoeksproduct en/of interventie
Low phosphate diet combined with phosphate supplement or placebo
Publiek
M.A. de Jong
Hanzeplein 1 Postbus 30.001
Groningen 9700 RB
The Netherlands
Phone +31 50 3615119
M.A.deJong03@umcg.nl
Wetenschappelijk
M.A. de Jong
Hanzeplein 1 Postbus 30.001
Groningen 9700 RB
The Netherlands
Phone +31 50 3615119
M.A.deJong03@umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Current use of phosphate binder therapy
• Hyperphosphatemia >2.00 mmol/L
• Hypocalcaemia (corrected serum calcium <2.00 mmol/L)
• Hypercalcaemia (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).
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5443 |
| NTR-old | NTR5570 |
| Ander register | UMCG : 201500492 |