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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01022060
First Posted: December 1, 2009
Last Update Posted: February 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Catalysis SL
  Purpose
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 Intervention Phase
Recurrent Calcic Urolithiasis Dietary Supplement: Renalof Dietary Supplement: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 110
Study Start Date: November 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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
  More Information

Responsible Party: Mirna Atiés Sánchez, Institute of Nephrology
ClinicalTrials.gov Identifier: NCT01022060     History of Changes
Other Study ID Numbers: CAT-0913-CU
First Submitted: November 27, 2009
First Posted: December 1, 2009
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