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Phosphate Reduction Or Supplementation Intervention Trial


- candidate number23402
- NTR NumberNTR5570
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-nov-2015
- Secondary IDs201500492 UMCG
- Public TitlePhosphate Reduction Or Supplementation Intervention Trial
- Scientific TitlePhosphate Reduction Or Supplementation Intervention Trial
- ACRONYMPROSIT
- hypothesisModulation of phosphate intake can affect the antiproteinuric efficacy of RAAS-blockade therapy in CKD patients
- Healt Condition(s) or Problem(s) studiedChronic kidney disease
- 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).
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2016
- planned closingdate1-jan-2018
- Target number of participants42
- InterventionsLow phosphate diet combined with phosphate supplement or placebo
- Primary outcomeResidual albuminuria (24h urine collection)
- Secondary outcomeC-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
- Timepointsweek 3 and 6 of each study period (cross-over)
- Trial web site
- statusrecruitement status not public
- CONTACT FOR PUBLIC QUERIESMD M.A. de Jong
- CONTACT for SCIENTIFIC QUERIESMD M.A. de Jong
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryChronic 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.
- Main changes (audit trail)
- RECORD17-nov-2015 - 14-feb-2016


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