NCT01022060

Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis

Efficacy of Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Catalysis SL · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Recurrent Calcic Urolithiasis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Renalof	One Renalof tablet (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 weeks
DIETARY_SUPPLEMENT	Placebo	One Placebo tablet (Orally administered) three time a day (just before each meal: breakfast, lunch and dinner), for 12 weeks

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2009-12-01
• Last updated: 2010-02-04

Locations

1 site across 1 country: Cuba