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

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

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.

Study Overview

• Status: Completed
• Conditions: Uropathy; Losartan Adverse Reaction; Uropathy Obstructive
• Intervention / Treatment: Drug: Placebo; Drug: Cozaar (Losartan Potassium 25mg)

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Outside U.S./Canada
    • Mansoura, Outside U.S./Canada, Egypt, 35516
      • Urology and nephrology center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Losartan; to receive the medication Cozaar (Losartan Potassium 25mg "Merck Sharp & Dohme-UK"),	Drug: Cozaar (Losartan Potassium 25mg); Cozaar (Losartan Potassium 25mg); Other Names: Cozaar
Placebo Comparator: Placebo; to receive either placebo	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renographic glomerular filtration rate of the affected kidney.	assessed by radioisotope renography using 99mTc-mercaptoacetyltriglycine (99mTc-MAG3) in ml/min	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum creatinine change	assessed by serum creatnine in mg/dl	3 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Ahmed Shokier, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Losartan
• Other Study ID Numbers: LOSARTAN.OBST.UROPATHY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No