Effects of Proton Pump Inhibitors on Kidney Transplant Recipients

NCT03123796 | Completed

• 1 other identifier: 332
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transplant Dysfunction; Magnesium Disorder

Keywords

chronic rejection; transplant outcome

Outcome Measures

Primary Outcomes (1)

• Graft survival

  5-10 years

Secondary Outcomes (1)

• Graft rejection

  5-10 years

Other Outcomes (1)

• Serum magnesium levels

  5-10 years

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients.

You may qualify if:

• 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).

You may not qualify if:

• Patients who are unwilling or unable to consent.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 26752337 BACKGROUND

• 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.

  PMID: 24659591 BACKGROUND

Study Officials

• Yasar Caliskan, MD

  Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 21, 2017
• Study Start: December 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 27, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)