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

NCT ID: NCT01022060

Last Updated: 2010-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Recurrent Calcic Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Renalof

Group Type EXPERIMENTAL

Renalof

Intervention Type DIETARY_SUPPLEMENT

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

B

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Renalof

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catalysis SL

INDUSTRY

Sponsor Role lead

Responsible Party

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Institute of Nephrology

Principal Investigators

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Mirna Atiés Sánchez, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Nephrology

Locations

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Institute of Nephrology

Havana, La Habana, Cuba

Site Status

Countries

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Cuba

Other Identifiers

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CAT-0913-CU

Identifier Type: -

Identifier Source: org_study_id

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