Trial reportBMC nephrology2012
Fibroblast growth factor 23 and parathyroid hormone after treatment with active vitamin D and sevelamer carbonate in patients with chronic kidney disease stage 3b, a randomized crossover trial.
Trial report in BMC nephrology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01231438 (An Open, Randomized, Crossover Phase 2 Pilot Study of Treatment of Stage 3B Renal Failure With Active Vitamin D or a Phosphate Binder to Evaluate the Effect on the FGF23 and PTH Levels.), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open, Randomized, Crossover Phase 2 Pilot Study of Treatment of Stage 3B Renal Failure With Active Vitamin D or a Phosphate Binder to Evaluate the Effect on the FGF23 and PTH Levels.
Who cites it
7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.
- Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD).The Cochrane database of systematic reviews · 2025Pooled it
- Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD).The Cochrane database of systematic reviews · 2018Pooled it
- Trial
- Dietary phosphorus restriction by a standard low-protein diet decreased serum fibroblast growth factor 23 levels in patients with early and advanced stage chronic kidney disease.Clinical and experimental nephrology · 2014Trial
- Fibroblast growth factor 23: are we ready to use it in clinical practice?Journal of nephrology · 2020Review
- Sevelamer carbonate: a review in hyperphosphataemia in adults with chronic kidney disease.Drugs · 2014Review
- Longitudinal Study to Find the Association of Serum Phosphorus Level with FGF23 in Three Different Hyperphosphatemia Management Groups of Stage 3 and 4 Chronic Kidney Disease (CKD) Patients.Indian journal of nephrologyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFibroblast growth factor 23 (FGF23) is a phosphaturic hormone that is secreted from bone and serum level increases as renal function declines. Higher levels of FGF23 are associated with increased mortality in hemodialysis-patients and in patients with chronic kidney disease (CKD) stage 2-4. The use of active vitamin D and phosphate binders as recommended in international guidelines, may affect the level of FGF23 and thereby clinical outcome. We investigated the effects of a phosphate binder and active vitamin D on the serum levels of intact FGF23 (iFGF23) and intact parathyroid hormone (iPTH) in patients with CKD stage 3b (glomerular filtration rate (GFR) 30-44 ml/min/1.73 m(2)).
methodsSeven women and 14 men were included, mean age 65.6 ± 12.2 years. They were randomized in a 1:1 ratio to receive one of two treatment sequences. Group-1 (the alphacalcidol-sevelamer carbonate group): alphacalcidol 0.25 μg once daily for two weeks followed by sevelamer carbonate 800 mg TID with meals for two weeks after a two-week washout period. Group-2 (the sevelamer carbonate-alphacalcidol group): vice versa. Nineteen patients completed the study. The 25-hydroxyvitamin D level at baseline was 97.6 ± 25.0 nmol/l.
resultsThere were no treatment effects on the iFGF23 and iPTH levels overall. In group-1 the iFGF23 level was higher after treatment with alphacalcidol compared with sevelamer carbonate (mean 105.8 ± 41.6 vs. 79.1 ± 36.5 pg/ml, p = 0.047 (CI: 0.4-52.9), and the iPTH level was lower (median: 26.5, range: 14.6-55.2 vs. median 36.1, range 13.4-106.9 pg/ml, p = 0.011). In group-2 the iFGF23 level increased non-significantly after treatment with sevelamer carbonate and throughout the washout period.
conclusionsIn this crossover trial with alphacalcidol and sevelamer carbonate in patients with CKD stage 3b, the levels of iFGF23 were not significantly different after the two treatments. However, in the group of patients initiating therapy with sevelamer carbonate the iFGF23 levels seemed to increase while this response was mitigated in the group of patients given alphacalcidol followed by sevelamer carbonate. This may have therapeutic implications on choice of first line therapy. The number of patients is small and this conclusion is in part based on subgroup analysis. It is therefore important that these results are confirmed in larger studies.
trial registrationTRIAL REGISTRATION NUMBER: European Clinical Trial Database (EudraCT) 2010-020415-36 and Clinical Trials.gov NCT01231438.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.