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Completed

NCT Number: NCT01022060

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.

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Key information

Conditions

Recurrent Calcic Urolithiasis Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Nephrology

Havana, La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renalof

Dietary Supplement

One Renalof tablet (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 weeks

Placebo

Dietary Supplement

One Placebo tablet (Orally administered) three time a day (just before each meal: breakfast, lunch and dinner), for 12 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 1, 2009
Registry last updated
Feb 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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