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Effect of Proton Pump Inhibitor of Daily Use for One Month on Kidney Function Test

A

Assiut University

Status and phase

Unknown
Phase 2

Conditions

Proton Pump Inhibitor Allergy

Treatments

Drug: Pantoprazole 40mg

Study type

Interventional

Funder types

Other

Identifiers

NCT04022837
PPIs on kidney

Details and patient eligibility

About

The aim of this study to:

evaluate the association between prolonged use of PPI and adverse renal outcomes on patients with normal renal function and others with abnormal renal function

Full description

Proton pump inhibitors (PPIs) are one of the most widely used classes of drugs and are prescribed primarily for gastric acid-related diseases, eradication of Helicobacter pylori, and prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced gastropathy,and gastroesophagial reflux diseases , Although PPIs have an excellent overall safety profile, some severe adverse effects, which include bone fracture, dementia, myocardial infarction, infections, micronutrient deficiencies, and kidney diseases, PPIs may trigger acute interstitial nephritis,a potentially sever adverse event commonly associated with acute kidney injury. The increase in prescription and inadequate use of this class of medication calls for studies on the effects of prolonged PPI therapy on renal function.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • patients with peptic ulcer disease or gastroesophagial reflux with normal l renal function
  • patients with peptic ulcer disease or gastroeosophagial reflux with abnormal renal function

Exclusion criteria

  • 1- cigarette smoker: Cigarette smoking status was defined categorically as current,former, or never smoker at baseline.

    2-biabetic patients: diabetes mellitus is defined by a fasting blood glucose concentration >_ 126 mg/dl ,random glucose level of >200 mg 3-patients take corticosteroid 4-patients with hypersensitivity to these drugs

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 2 patient groups

pantoprazole with normal kidney function
Experimental group
Description:
use pantoprazole for one month and after one month i will do for them kidney functions test
Treatment:
Drug: Pantoprazole 40mg
pantoprazole with abnormal kidney function
Experimental group
Description:
use pantoprazole for one month and after one month i will do for them kidney functions test
Treatment:
Drug: Pantoprazole 40mg

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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