NCT04278495

Brief Summary

Previous experimental studies concluded that angiotensin receptor blockers can ameliorate the harmful inflammatory and histological changes after relief of obstruction. Nevertheless, these witnessed effects have not been yet translated into the clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

4.3 years

First QC Date

February 18, 2020

Last Update Submit

February 19, 2020

Conditions

Losartan Adverse ReactionUropathyUropathy Obstructive

Outcome Measures

Primary Outcomes (1)

  • Renographic glomerular filtration rate of the affected kidney.

    assessed by radioisotope renography using 99mTc-mercaptoacetyltriglycine (99mTc-MAG3) in ml/min

    3 months

Secondary Outcomes (1)

  • Serum creatinine change

    3 months

Study Arms (2)

Losartan

ACTIVE COMPARATOR

to receive the medication Cozaar (Losartan Potassium 25mg "Merck Sharp \& Dohme-UK"),

Drug: Cozaar (Losartan Potassium 25mg)

Placebo

PLACEBO COMPARATOR

to receive either placebo

Drug: Placebo

Interventions

Cozaar (Losartan Potassium 25mg)DRUG

Cozaar (Losartan Potassium 25mg)

Also known as: Cozaar
Losartan
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • anuric and oliguric patients
  • calculuar ureteral obstruction

You may not qualify if:

  • anomalous kidney
  • bilateral obstructed kidney
  • history of recent use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors
  • ASA score of \>3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and nephrology center

Al Mansurah, Outside U.S./Canada, 35516, Egypt

Location

MeSH Terms

Conditions

Urologic Diseases

Interventions

Losartan

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Ahmed Shokier

    Mansoura University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

September 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)