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

Primary Purpose

Recurrent Calcic Urolithiasis

Status
Completed
Phase
Phase 3
Locations
Cuba
Study Type
Interventional
Intervention
Renalof
Placebo
Sponsored by
Catalysis SL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Calcic Urolithiasis focused on measuring Dietary supplement, Renalof, Recurrent calcic urolithiasis, Renal calculi

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institute of Nephrology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Renalof

Placebo

Outcomes

Primary Outcome Measures

Size of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment)
Number of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment
Lithiasic activity at week 12 (end of the treatment); week 0 refers to the beginning of treatment

Secondary Outcome Measures

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

Full Information

First Posted
November 27, 2009
Last Updated
February 3, 2010
Sponsor
Catalysis SL
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1. Study Identification

Unique Protocol Identification Number
NCT01022060
Brief Title
Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis
Official Title
Efficacy of Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Catalysis SL

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Calcic Urolithiasis
Keywords
Dietary supplement, Renalof, Recurrent calcic urolithiasis, Renal calculi

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Renalof
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Renalof
Intervention Description
One Renalof tablet (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
One Placebo tablet (Orally administered) three time a day (just before each meal: breakfast, lunch and dinner), for 12 weeks
Primary Outcome Measure Information:
Title
Size of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment)
Time Frame
12 weeks
Title
Number of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment
Time Frame
12 weeks
Title
Lithiasic activity at week 12 (end of the treatment); week 0 refers to the beginning of treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Calciuria at week 12
Time Frame
12 weeks
Title
Uricosuria at week 12
Time Frame
12 weeks
Title
Blood Uric acid at week 12
Time Frame
12 weeks
Title
Oxaluria at week 12
Time Frame
12 weeks
Title
Citraturia at week 12
Time Frame
12 weeks
Title
Phosphatemia at week 12
Time Frame
12 weeks
Title
Calcemia at week 12
Time Frame
12 weeks
Title
Total plasmatic calcium at week 12
Time Frame
12 weeks
Title
Blood ionic calcium at week 12
Time Frame
12 weeks
Title
Calcium Oxalate crystallization risk at week 12
Time Frame
12 weeks
Title
Calcium phosphate activity product at week 12
Time Frame
12 weeks
Title
Calcium Oxalate activity product at week 12
Time Frame
12 weeks
Title
pH of urine at week 12
Time Frame
12 weeks
Title
Presence of adverse effects at any moment of treatment
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirna Atiés Sánchez, MD
Organizational Affiliation
Institute of Nephrology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Nephrology
City
Havana City
State/Province
Havana
ZIP/Postal Code
10400
Country
Cuba

12. IPD Sharing Statement

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

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