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

February 3, 2010 updated by: Catalysis SL

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
    • Havana
      • Havana City, Havana, Cuba, 10400
        • Institute of Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: B
Placebo
Dietary supplement: Placebo
One Placebo tablet (Orally administered) three time a day (just before each meal: breakfast, lunch and dinner), for 12 weeks
EXPERIMENTAL: A
Renalof
Dietary supplement: Renalof
One Renalof tablet (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Size of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment)
Time Frame: 12 weeks
12 weeks
Number of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment
Time Frame: 12 weeks
12 weeks
Lithiasic activity at week 12 (end of the treatment); week 0 refers to the beginning of treatment
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Investigators

  • Principal Investigator: Mirna Atiés Sánchez, MD, Institute of Nephrology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

November 27, 2009

First Submitted That Met QC Criteria

November 27, 2009

First Posted (ESTIMATE)

December 1, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 4, 2010

Last Update Submitted That Met QC Criteria

February 3, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT-0913-CU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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