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

NCT01022060 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2010-02-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Catalysis SL

    lead INDUSTRY

Principal Investigators

  • Mirna Atiés Sánchez, MD · Institute of Nephrology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Cuba

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01022060 on ClinicalTrials.gov