CClinicalTrials.gg
Sign In
CompletedNCT03123796Updated Dec 27, 2017

Effects of Proton Pump Inhibitors on Kidney Transplant Recipients

An observational study in Transplant Dysfunction and Magnesium Disorder, sponsored by Istanbul University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-27.

Sponsored by Istanbul University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study summary

Use of proton pump inhibitors (PPIs) is quite common among renal transplant recipients and reduced kidney functions and hypomagnesemia with the use of PPIs have been reported. In this study, investigation of the effects of PPI use on the outcome of kidney transplant recipients is aimed.

Read the detailed description

Use of proton pump inhibitors (PPIs) is frequent among renal transplant recipients due to the common use of glucocorticoids in immunosuppresive regimens after transplantation. Reduced kidney functions and hypomagnesemia with the use of PPIs have been reported in various patient populations. However, few studies examined the effects of PPIs on kidney transplant recipients. Therefore, the aim of this study is to investigate the effects of PPI and/or histamine H2 receptor antagonist use on serum magnesium levels, allograft functions and survival in kidney transplant recipients.

02

Conditions studied

  • Transplant Dysfunction
  • Magnesium Disorder

Keywords

  • chronic rejection
  • transplant outcome
03

In context

Lead sponsor

Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Kidney transplant recipients.

Inclusion criteria

  • Kidney transplant recipients who used only proton pump inhibitors and did not use histamine H2 receptor antagonists (Only PPI).
  • Kidney transplant recipients who used histamine H2 receptor antagonists and did not use proton pump inhibitors (Only H2RA).
  • Kidney transplant recipients who used both proton pump inhibitors and histamine H2 receptor antagonists (PPI and H2RA).
  • Kidney transplant recipients who used neither proton pump inhibitors nor histamine H2 receptor antagonists (No Acid Suppressive Treatment).

Exclusion criteria

Exclusion Criteria:

  • Patients who are unwilling or unable to consent.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
300 participants (actual)
Patient registry
No

Groups and cohorts

  • Only PPI

    Kidney transplant recipients who used only proton pump inhibitors and did not use histamine H2 receptor antagonists.

  • Only H2RA

    Kidney transplant recipients who used only histamine H2 receptor antagonists and did not use proton pump inhibitors.

  • PPI and H2RA

    Kidney transplant recipients who used both proton pump inhibitors and histamine H2 receptor antagonists.

  • No Acid Suppressive Treatment

    Kidney transplant recipients who used neither proton pump inhibitors nor histamine H2 receptor antagonists.

06

What researchers measure

Primary outcomes

  1. Graft survival

    Time frame: 5-10 years

Secondary outcomes

  1. Graft rejection

    Time frame: 5-10 years

Other outcomes

  1. Serum magnesium levels

    Time frame: 5-10 years

07

Study locations

1 site
  • Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
    İstanbul, 34093, Turkey
08

References and documents

Publications

  • Lazarus B, Chen Y, Wilson FP, Sang Y, Chang AR, Coresh J, Grams ME. Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease. JAMA Intern Med. 2016 Feb;176(2):238-46. doi: 10.1001/jamainternmed.2015.7193. PubMed 26752337 ↗
  • van Boekel GA, Kerkhofs CH, van de Logt F, Hilbrands LB. Proton pump inhibitors do not increase the risk of acute rejection. Neth J Med. 2014 Feb;72(2):86-90. PubMed 24659591 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03123796
Lead sponsor
Istanbul University
Responsible party
Yasar Caliskan (Associate Professor of Medicine, Istanbul University) — Principal investigator
First posted
Apr 21, 2017
Start date
Dec 2016
Primary completion
Sep 2017
Completion
Nov 2017
Last update
Dec 27, 2017

Study contacts

Yasar Caliskan, MD
principal investigator · Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Istanbul University

Start the discussion