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

Phase 2

• Conditions: Proton Pump Inhibitor Allergy
• Interventions: Drug: pantoprazole

• Registration Number: NCT03910647
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-10
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-17
• Study Start: 2019-12
• Primary Completion: 2020-12
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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/dl.

  3-patients take corticosteroid 4-patients with hypersensitivity to these drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pantoprazole with abnormal kidney function	pantoprazole	use pantoprazole for one month and after one month i will do for them kidney functions test
pantoprazole with normal kidney function	pantoprazole	use pantoprazole for one month and after one month i will do for them kidney functions test

Primary Outcome Measures

Name	Time	Method
kidney function	one month	eGFR=175xage(y/0)x\^(-0.203)xplasma creatinine (mg/dl)x\^(-1.154)