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

Phase 3

Completed

• Conditions: Recurrent Calcic Urolithiasis
• Interventions: Dietary Supplement: Renalof; Dietary Supplement: Placebo

• Registration Number: NCT01022060
• Lead Sponsor: Catalysis SL

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-27
• Study First Submitted QC: 2009-11-27
• Study First Posted: 2009-12-01
• Status Verified: 2010-02
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2010-02-03
• Last Update Posted: 2010-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Idiopathic calcic lithiasis
• Calculus size lesser than or equal to 2.0 cm (0.79 inches)
• Signed informed consent

Exclusion Criteria

• Calculus size greater than 2,0 cm (0.79 inches)
• Pregnancy
• Malignant neoplastic conditions
• Previous treatment for destruction of calculi in the urinary tract

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Renalof	Renalof
B	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Size of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment)	12 weeks
Number of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment	12 weeks
Lithiasic activity at week 12 (end of the treatment); week 0 refers to the beginning of treatment	12 weeks

Secondary Outcome Measures

Name	Time	Method
Calciuria at week 12	12 weeks
Uricosuria at week 12	12 weeks
Blood Uric acid at week 12	12 weeks
Oxaluria at week 12	12 weeks
Citraturia at week 12	12 weeks
Phosphatemia at week 12	12 weeks
Calcemia at week 12	12 weeks
Total plasmatic calcium at week 12	12 weeks
Blood ionic calcium at week 12	12 weeks
Calcium Oxalate crystallization risk at week 12	12 weeks
Calcium phosphate activity product at week 12	12 weeks
Calcium Oxalate activity product at week 12	12 weeks
pH of urine at week 12	12 weeks
Presence of adverse effects at any moment of treatment	12 weeks

Trial Locations

Locations (1)

Institute of Nephrology; 🇨🇺 Havana City, Havana, Cuba