Back to resultsRenalof 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
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
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
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
Learn more about this trial
Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis
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