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

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

Study Overview

• Status: Unknown
• Conditions: Proton Pump Inhibitor Allergy
• Intervention / Treatment: Drug: Pantoprazole 40mg

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pantoprazole with normal kidney function; use pantoprazole for one month and after one month i will do for them kidney functions test	Drug: Pantoprazole 40mg; effect of this drug on renal function; Other Names: Protonix
Experimental: pantoprazole with abnormal kidney function; use pantoprazole for one month and after one month i will do for them kidney functions test	Drug: Pantoprazole 40mg; effect of this drug on renal function; Other Names: Protonix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
kidney function	eGFR=175xage(y/0)x^(-0.203)xplasma creatinine (mg/dl)x^(-1.154)	one month

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: PPIs on kidney

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No