NCT01022060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 4, 2010

Status Verified

February 1, 2010

Enrollment Period

3 months

First QC Date

November 27, 2009

Last Update Submit

February 3, 2010

Conditions

Recurrent Calcic Urolithiasis

Keywords

Dietary supplementRenalofRecurrent calcic urolithiasisRenal calculi

Outcome Measures

Primary Outcomes (3)

  • Size of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment)

    12 weeks

  • Number of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment

    12 weeks

  • Lithiasic activity at week 12 (end of the treatment); week 0 refers to the beginning of treatment

    12 weeks

Secondary Outcomes (14)

  • Calciuria at week 12

    12 weeks

  • Uricosuria at week 12

    12 weeks

  • Blood Uric acid at week 12

    12 weeks

  • Oxaluria at week 12

    12 weeks

  • Citraturia at week 12

    12 weeks

  • +9 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Renalof

Dietary Supplement: Renalof

B

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

RenalofDIETARY_SUPPLEMENT

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

A
PlaceboDIETARY_SUPPLEMENT

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

B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic calcic lithiasis
  • Calculus size lesser than or equal to 2.0 cm (0.79 inches)
  • Signed informed consent

You may not qualify if:

  • Calculus size greater than 2,0 cm (0.79 inches)
  • Pregnancy
  • Malignant neoplastic conditions
  • Previous treatment for destruction of calculi in the urinary tract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nephrology

Havana, La Habana, 10400, Cuba

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mirna Atiés Sánchez, MD

    Institute of Nephrology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 27, 2009

First Posted

December 1, 2009

Study Start

November 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

February 4, 2010

Record last verified: 2010-02

Locations

CU(1)