Recurrent Calcic UrolithiasisPhase 3NCT01022060
Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis
A Phase 3 study testing Renalof in people with Recurrent Calcic Urolithiasis, run by Catalysis SL at 1 site in Cuba.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Recurrent Calcic Urolithiasis
- What is being tested?
- Renalof
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteCuba
- Study dates
- Nov 2009to Feb 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic calcic lithiasis
- Calculus size lesser than or equal to 2.0 cm (0.79 inches)
- Signed informed consent
Who cannot join
- Calculus size greater than 2,0 cm (0.79 inches)
- Pregnancy
- Malignant neoplastic conditions
- Previous treatment for destruction of calculi in the urinary tract
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Recurrent Calcic Urolithiasis
- Being tested
- Renalof, Placebo
- Keywords
- Dietary supplement, Renalof, Recurrent calcic urolithiasis, Renal calculi
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenalofDietary supplement
One Renalof tablet (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 weeks
PlaceboDietary supplement
One Placebo tablet (Orally administered) three time a day (just before each meal: breakfast, lunch and dinner), for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Renalof Receives: Dietary Supplement: Renalof |
| B | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment)
Measured: 12 weeks
Number of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment
Measured: 12 weeks
Lithiasic activity at week 12 (end of the treatment); week 0 refers to the beginning of treatment
Measured: 12 weeks
Secondary outcomes (14)
Calciuria at week 12
Measured: 12 weeks
Uricosuria at week 12
Measured: 12 weeks
Blood Uric acid at week 12
Measured: 12 weeks
Oxaluria at week 12
Measured: 12 weeks
Citraturia at week 12
Measured: 12 weeks
Phosphatemia at week 12
Measured: 12 weeks
Calcemia at week 12
Measured: 12 weeks
Total plasmatic calcium at week 12
Measured: 12 weeks
Blood ionic calcium at week 12
Measured: 12 weeks
Calcium Oxalate crystallization risk at week 12
Measured: 12 weeks
Calcium phosphate activity product at week 12
Measured: 12 weeks
Calcium Oxalate activity product at week 12
Measured: 12 weeks
pH of urine at week 12
Measured: 12 weeks
Presence of adverse effects at any moment of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Calcic UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mirna Atiés Sánchez, MD, Principal investigator, Institute of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022060
- Sponsor's protocol ID
- CAT-0913-CU
- Status last verified
- Feb 2010
- First submitted
- 27 Nov 2009
- Last updated
- 4 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis
- ClinicalTrials.gov ID
- NCT01022060
- Acronym / sponsor ID
- CAT-0913-CU
- Conditions
- Recurrent Calcic Urolithiasis
- Keywords
- Dietary supplement, Renalof, Recurrent calcic urolithiasis, Renal calculi
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: RenalofRenalof |
| B | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic calcic lithiasis
- Calculus size lesser than or equal to 2.0 cm (0.79 inches)
- Signed informed consent
Key exclusion criteria (4 listed)
- Calculus size greater than 2,0 cm (0.79 inches)
- Pregnancy
- Malignant neoplastic conditions
- Previous treatment for destruction of calculi in the urinary tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RenalofOne Renalof tablet (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 weeks | Dietary supplement | A |
| PlaceboOne Placebo tablet (Orally administered) three time a day (just before each meal: breakfast, lunch and dinner), for 12 weeks | Dietary supplement | B |
Primary outcome
Size of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment)
Time frame: 12 weeks
Number of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment
Time frame: 12 weeks
Lithiasic activity at week 12 (end of the treatment); week 0 refers to the beginning of treatment
Time frame: 12 weeks
14 secondary outcomes
Calciuria at week 12
Time frame: 12 weeks
Uricosuria at week 12
Time frame: 12 weeks
Blood Uric acid at week 12
Time frame: 12 weeks
Oxaluria at week 12
Time frame: 12 weeks
Citraturia at week 12
Time frame: 12 weeks
Phosphatemia at week 12
Time frame: 12 weeks
Calcemia at week 12
Time frame: 12 weeks
Total plasmatic calcium at week 12
Time frame: 12 weeks
Blood ionic calcium at week 12
Time frame: 12 weeks
Calcium Oxalate crystallization risk at week 12
Time frame: 12 weeks
Calcium phosphate activity product at week 12
Time frame: 12 weeks
Calcium Oxalate activity product at week 12
Time frame: 12 weeks
pH of urine at week 12
Time frame: 12 weeks
Presence of adverse effects at any moment of treatment
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirna Atiés Sánchez, MD principal investigator
Institute of Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Renalof in people with Recurrent Calcic Urolithiasis, run by Catalysis SL at 1 site in Cuba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2010.