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

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

Sponsors

Lead sponsor: Catalysis SL

Source 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.

Overall Status Completed
Start Date November 2009
Completion Date February 2010
Primary Completion Date February 2010
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
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
Enrollment 110
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Renalof

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

Arm group label: A

Intervention type: Dietary Supplement

Intervention name: Placebo

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

Arm group label: B

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Mirna Atiés Sánchez, MD Principal Investigator Institute of Nephrology
Location
facility Institute of Nephrology
Location Countries

Cuba

Verification Date

February 2010

Responsible Party

Name title: Mirna Atiés Sánchez

Organization: Institute of Nephrology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: A

Arm group type: Experimental

Description: Renalof

Arm group label: B

Arm group type: Placebo Comparator

Description: Placebo

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov