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

Recurrent Calcic Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022060
• Other study ID #: CAT-0913-CU
• Status: Completed
• Phase: Phase 3
• First received: November 27, 2009
• Last updated: February 3, 2010
• Start date: November 2009
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Recurrent Calcic Urolithiasis
• Urolithiasis

Intervention

Dietary Supplement:
• Renalof
One Renalof tablet (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 weeks
• Placebo
One Placebo tablet (Orally administered) three time a day (just before each meal: breakfast, lunch and dinner), for 12 weeks

Locations

Country	Name	City	State
Cuba	Institute of Nephrology	Havana City	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment)		12 weeks	No
Primary	Number of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment		12 weeks	No
Primary	Lithiasic activity at week 12 (end of the treatment); week 0 refers to the beginning of treatment		12 weeks	No
Secondary	Calciuria at week 12		12 weeks	No
Secondary	Uricosuria at week 12		12 weeks	No
Secondary	Blood Uric acid at week 12		12 weeks	No
Secondary	Oxaluria at week 12		12 weeks	No
Secondary	Citraturia at week 12		12 weeks	No
Secondary	Phosphatemia at week 12		12 weeks	No
Secondary	Calcemia at week 12		12 weeks	No
Secondary	Total plasmatic calcium at week 12		12 weeks	No
Secondary	Blood ionic calcium at week 12		12 weeks	No
Secondary	Calcium Oxalate crystallization risk at week 12		12 weeks	No
Secondary	Calcium phosphate activity product at week 12		12 weeks	No
Secondary	Calcium Oxalate activity product at week 12		12 weeks	No
Secondary	pH of urine at week 12		12 weeks	No
Secondary	Presence of adverse effects at any moment of treatment		12 weeks	Yes