Abstract | BACKGROUND: METHODS:
Phosphate binders were discontinued during a 2-week washout period. Subsequently, patients whose serum phosphorus levels were > or =6.5 mg/dl, but <10 mg/dl were eligible to enter the treatment protocol. Patients were randomized to either MCI-196 6 g/day or placebo for 2 weeks. The efficacy and safety of MCI-196 were assessed in 33 and 46 patients, respectively. RESULTS: Serum phosphorus in the placebo group increased by 0.84+/-0.95 mg/dl (mean+/-SD), while serum phosphorus in the MCI-196 group decreased by 0.55+/-1.23 mg/dl. The difference between the two groups was statistically significant (P = 0.002). A reduction of > or =1 mg/dl in serum phosphorus was observed in 43% in the MCI-196 group and 0% of patients in the placebo group (P = 0.0122). Calcium- phosphorus (Ca x P) product, intact parathyroid hormone (iPTH) and low-density lipoprotein ( LDL)-cholesterol in the MCI-196 group also decreased significantly compared with the placebo group, while serum calcium was unchanged. Adverse reactions were observed in 51.7% of the MCI-196 group and 29.4% of the placebo group (P = 0.2186). The most frequent adverse reactions in the MCI-196 group were gastrointestinal symptoms and signs, including constipation. CONCLUSIONS: The present findings suggest that the short-term administration of MCI-196 is effective in decreasing serum phosphorus in haemodialysis patients. Its long-term efficacy needs to be evaluated.
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Authors | Satoshi Kurihara, Yoshinari Tsuruta, Tadao Akizawa |
Journal | Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
(Nephrol Dial Transplant)
Vol. 20
Issue 2
Pg. 424-30
(Feb 2005)
ISSN: 0931-0509 [Print] England |
PMID | 15673691
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Bile Acids and Salts
- Cholesterol, HDL
- Cholesterol, LDL
- Parathyroid Hormone
- Phosphates
- Placebos
- Phosphorus
- Cholesterol
- Calcium
- cholebine
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Topics |
- Bile Acids and Salts
(therapeutic use)
- Calcium
(blood)
- Cholesterol
(blood)
- Cholesterol, HDL
(blood)
- Cholesterol, LDL
(blood)
- Double-Blind Method
- Female
- Humans
- Kidney Failure, Chronic
(complications, therapy)
- Male
- Middle Aged
- Parathyroid Hormone
(blood)
- Phosphates
(metabolism)
- Phosphorus
(blood)
- Phosphorus Metabolism Disorders
(drug therapy, etiology)
- Placebos
- Renal Dialysis
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