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

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ClinicalTrials.gov Identifier: NCT01022060
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : February 4, 2010
Sponsor:
Information provided by:
Catalysis SL

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.

Condition or disease Intervention/treatment Phase
Recurrent Calcic Urolithiasis Dietary Supplement: Renalof Dietary Supplement: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis
Study Start Date : November 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Size of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment) [ Time Frame: 12 weeks ]
  2. Number of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment [ Time Frame: 12 weeks ]
  3. Lithiasic activity at week 12 (end of the treatment); week 0 refers to the beginning of treatment [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Calciuria at week 12 [ Time Frame: 12 weeks ]
  2. Uricosuria at week 12 [ Time Frame: 12 weeks ]
  3. Blood Uric acid at week 12 [ Time Frame: 12 weeks ]
  4. Oxaluria at week 12 [ Time Frame: 12 weeks ]
  5. Citraturia at week 12 [ Time Frame: 12 weeks ]
  6. Phosphatemia at week 12 [ Time Frame: 12 weeks ]
  7. Calcemia at week 12 [ Time Frame: 12 weeks ]
  8. Total plasmatic calcium at week 12 [ Time Frame: 12 weeks ]
  9. Blood ionic calcium at week 12 [ Time Frame: 12 weeks ]
  10. Calcium Oxalate crystallization risk at week 12 [ Time Frame: 12 weeks ]
  11. Calcium phosphate activity product at week 12 [ Time Frame: 12 weeks ]
  12. Calcium Oxalate activity product at week 12 [ Time Frame: 12 weeks ]
  13. pH of urine at week 12 [ Time Frame: 12 weeks ]
  14. Presence of adverse effects at any moment of treatment [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022060


Locations
Cuba
Institute of Nephrology
Havana City, Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Mirna Atiés Sánchez, MD Institute of Nephrology

Responsible Party: Mirna Atiés Sánchez, Institute of Nephrology
ClinicalTrials.gov Identifier: NCT01022060     History of Changes
Other Study ID Numbers: CAT-0913-CU
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: February 2010

Keywords provided by Catalysis SL:
Dietary supplement
Renalof
Recurrent calcic urolithiasis
Renal calculi

Additional relevant MeSH terms:
Calculi
Urolithiasis
Kidney Calculi
Nephrolithiasis
Lithiasis
Pathological Conditions, Anatomical
Urologic Diseases
Kidney Diseases
Urinary Calculi
Pathologic Processes