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

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Recurrent Calcic Urolithiasis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Renalof

Study type: Interventional

Funder types: Industry

Identifiers

NCT01022060

CAT-0913-CU

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Renalof

Treatment:

Dietary Supplement: Renalof

B

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo