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

This study has been completed.
Sponsor:
Information provided by:
Catalysis SL
ClinicalTrials.gov Identifier:
NCT01022060
First received: November 27, 2009
Last updated: February 3, 2010
Last verified: February 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
  • Number of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Lithiasic activity at week 12 (end of the treatment); week 0 refers to the beginning of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Calciuria at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Uricosuria at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Blood Uric acid at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Oxaluria at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Citraturia at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Phosphatemia at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Calcemia at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Total plasmatic calcium at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Blood ionic calcium at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Calcium Oxalate crystallization risk at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Calcium phosphate activity product at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Calcium Oxalate activity product at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • pH of urine at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Presence of adverse effects at any moment of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mirna Atiés Sánchez, Institute of Nephrology
ClinicalTrials.gov Identifier: NCT01022060     History of Changes
Other Study ID Numbers: CAT-0913-CU
Study First Received: November 27, 2009
Last Updated: February 3, 2010
Health Authority: Cuba: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 19, 2014