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The Effect of Losartan on the Recoverability of Renal Function in Anuric and Oliguric Patients With Unilateral Obstructed Kidney

Primary Purpose

Losartan Adverse Reaction, Uropathy, Uropathy Obstructive

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Cozaar (Losartan Potassium 25mg)

Placebo

About this trial

This is an interventional treatment trial for Losartan Adverse Reaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

anuric and oliguric patients
calculuar ureteral obstruction

Exclusion Criteria:

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

Sites / Locations

Urology and nephrology center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Losartan

Placebo

Arm Description

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

to receive either placebo

Outcomes

Primary Outcome Measures

Renographic glomerular filtration rate of the affected kidney.

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

Secondary Outcome Measures

Serum creatinine change

assessed by serum creatnine in mg/dl

Full Information

NCT ID

NCT04278495

First Posted

February 18, 2020

Last Updated

February 19, 2020

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT04278495

Brief Title

The Effect of Losartan on the Recoverability of Renal Function in Anuric and Oliguric Patients With Unilateral Obstructed Kidney

Official Title

The Effect of Losartan on the Recoverability of Renal Function in Anuric and Oliguric Patients With Unilateral Obstructed Kidney: A Double Blind Randomized Placebo-controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

September 1, 2014 (Actual)

Primary Completion Date

December 1, 2018 (Actual)

Study Completion Date

December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Losartan Adverse Reaction, Uropathy, Uropathy Obstructive

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Losartan

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

to receive either placebo

Intervention Type

Drug

Intervention Name(s)

Cozaar (Losartan Potassium 25mg)

Other Intervention Name(s)

Cozaar

Intervention Description

Cozaar (Losartan Potassium 25mg)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Renographic glomerular filtration rate of the affected kidney.

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Serum creatinine change

Description

assessed by serum creatnine in mg/dl

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: anuric and oliguric patients calculuar ureteral obstruction Exclusion Criteria: anomalous kidney bilateral obstructed kidney history of recent use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors ASA score of >3

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Shokier

Organizational Affiliation

Mansoura University

Official's Role

Study Chair

Facility Information:

Facility Name

Urology and nephrology center

City

Mansoura

State/Province

Outside U.S./Canada

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Effect of Losartan on the Recoverability of Renal Function in Anuric and Oliguric Patients With Unilateral Obstructed Kidney

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