No registrations found.
ID
Source
Brief title
Health condition
Chronic Kidney Disease (chronische nierinsufficiëntie)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Residual albuminuria (24h urine collection)
Secondary outcome
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
Background summary
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.
Study objective
Modulation of phosphate intake can affect the antiproteinuric efficacy of RAAS-blockade therapy in CKD patients
Study design
week 3 and 6 of each study period (cross-over)
Intervention
Low phosphate diet combined with phosphate supplement or placebo
M.A. de Jong
Hanzeplein 1 Postbus 30.001
Groningen 9700 RB
The Netherlands
Phone +31 50 3615119
M.A.deJong03@umcg.nl
M.A. de Jong
Hanzeplein 1 Postbus 30.001
Groningen 9700 RB
The Netherlands
Phone +31 50 3615119
M.A.deJong03@umcg.nl
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
• 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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5443 |
| NTR-old | NTR5570 |
| Other | UMCG : 201500492 |