The purpose of this study is to determine whether Renalof administration promotes partial or total dissolution of urinary calculi and improves physicochemical parameters and metabolic activity in patients with recurrent calcic urolithiasis. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of patients to be recruited and randomized for the study is 110. Ultrasonographic and humoral parameters will be assessed every 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
110
Institute of Nephrology
Havana, La Habana, Cuba
Size of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment)
Time frame: 12 weeks
Number of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment
Time frame: 12 weeks
Lithiasic activity at week 12 (end of the treatment); week 0 refers to the beginning of treatment
Time frame: 12 weeks
Calciuria at week 12
Time frame: 12 weeks
Uricosuria at week 12
Time frame: 12 weeks
Blood Uric acid at week 12
Time frame: 12 weeks
Oxaluria at week 12
Time frame: 12 weeks
Citraturia at week 12
Time frame: 12 weeks
Phosphatemia at week 12
Time frame: 12 weeks
Calcemia at week 12
Time frame: 12 weeks
Total plasmatic calcium at week 12
Time frame: 12 weeks
Blood ionic calcium at week 12
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Calcium Oxalate crystallization risk at week 12
Time frame: 12 weeks
Calcium phosphate activity product at week 12
Time frame: 12 weeks
Calcium Oxalate activity product at week 12
Time frame: 12 weeks
pH of urine at week 12
Time frame: 12 weeks
Presence of adverse effects at any moment of treatment
Time frame: 12 weeks