NCT01088555

Brief Summary

Sodium thiosulfate may be useful to prevent recurrence of calcium-containing kidney stones. It will be studied in people with high amounts of urine calcium.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

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
5 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 24, 2013

Status Verified

December 1, 2013

Enrollment Period

2.1 years

First QC Date

March 16, 2010

Last Update Submit

December 23, 2013

Conditions

Kidney Stones

Keywords

nephrolithiasiscalcium stoneskidney stoneshypercalciuriasodium thiosulfateCalcium containing kidney stones

Outcome Measures

Primary Outcomes (1)

  • Change in supersaturation of calcium oxalate / phosphate

    1 week

Study Arms (2)

Control group

ACTIVE COMPARATOR

Healthy subjects with no history of kidney stones, heart liver or kidney disease, not pregnant /lactating.

Drug: Sodium thiosulfate

Stone formers

ACTIVE COMPARATOR

History of calcium containing kidney stones, hypercalciuria on previous urine tests, no heart /liver / kidney disease, not pregnant/lactating

Drug: Sodium thiosulfate

Interventions

Sodium thiosulfateDRUG

Oral administration of sodium thiosulfate pentahydrate 5% solution (American Regent) 10ml BID x 7 days

Control groupStone formers

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Control arm: no longer recruiting
  • Hypercalciuria arm:
  • Age 18-80 years old
  • history of calcium-containing kidney stones
  • no history of liver, heart or kidney disease (other than kidney stones)
  • Non-pregnant, non-lactating
  • Able to stop diuretics for a period of 1 week

You may not qualify if:

  • Not able to sign consent
  • Not satisfying any of the above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA New York Harbor Healthcare System

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Kidney CalculiNephrolithiasisHypercalciuria

Interventions

sodium thiosulfate

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrological ManifestationsSigns and Symptoms

Study Officials

  • David S Goldfarb, MD

    New York Harbor VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

March 16, 2010

First Posted

March 17, 2010

Study Start

November 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 24, 2013

Record last verified: 2013-12

Locations

US(1)