Esomeprazole or Pantoprazole in Renal Transplantation

NCT03812419 | Completed

• 1 other identifier: 7-2015/22
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

prospective, parallel, open-label clinical trial was performed on forty-seven adult renal transplant recipients receiving immunosuppressive therapy with CsA doses adjusted to attain trough concentrations of 100-150 μg/L, mycophenolate mofetil (MMF) at 750 mg q12 hr and prednisolone at 5 mg daily randomized into two groups, which received esomeprazole or pantoprazole at the same dose (40 mg once daily). To compare the influence of pantoprazole and esomeprazole on serum cyclosporine (CsA) levels in stable renal transplant recipients.Cyclosporine (C0), renal function and complete blood count were measured at baseline and for 6 months. Main outcome measures Clinical signs of rejection and renal function decline, assessed by serum creatinine elevations, caused by CsA level variations in either of the study groups.

Conditions

Kidney Transplant; Complications

Keywords

Allograft rejection; cyclosporine; kidney transplantation; proton pump inhibitors; gastric complications.

Outcome Measures

Primary Outcomes (1)

• Serum CsA (C0) level

  trough CsA serum levels in µg/L

  up to 30 weeks from date of randomization untill date of any documented change in the serum concentration

Secondary Outcomes (1)

• Serum creatinine

  up to 30 weeks from date of randomization untill date of any documented change in the serum concentration

Other Outcomes (1)

• number of participants with signs of rejection

  up to 30 weeks from date of randomization untill date of any documented rejectionoccurence of

Study Arms (2)

group I

ACTIVE COMPARATOR

Esomeprazole 40 mg capsules once daily for 6 months

Drug: Esomeprazole 40 mg

group II

ACTIVE COMPARATOR

Pantoprazole 40 mg tablets once daily for 6 months

Drug: Pantoprazole 40mg

Interventions

Esomeprazole 40 mg DRUG

Esomeprazole 40 mg In addition, the immunosuppressant combination of CsA (Sandimmune; Novartis, East Hanover, NJ, USA), MMF (Cellcept; Roche, Basel, Switzerland) and the corticosteroid prednisolone (Solupred; Sanofi Aventis, Tours, France).

Also known as: Ezogast

group I

Pantoprazole 40mg DRUG

Pantoprazole 40 mg In addition, the immunosuppressant combination of CsA (Sandimmune; Novartis, East Hanover, NJ, USA), MMF (Cellcept; Roche, Basel, Switzerland) and the corticosteroid prednisolone (Solupred; Sanofi Aventis, Tours, France).

Also known as: Pantoprazole

group II

Eligibility Criteria

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

You may qualify if:

• stable adult renal transplant recipients
• participants continued the same maintenance triple immunosuppressive therapy,
• triple immunosuppressive therapy was received for at least 3 years prior to the study
• transplanted 5 years before the start of the study

You may not qualify if:

• Paediatric patients
• patients \> 65 years old
• multi-organ transplant recipients
• pregnant or lactating patients
• patients with malignancies,
• patients with active infection or inflammation
• pre-transplant GI tract disorders

Sponsors & Collaborators

• Future University in Egypt: lead
• Ain Shams University: collaborator
• Nasser Institute For Research and Treatment: collaborator

MeSH Terms

Interventions

Esomeprazole; Pantoprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Doaa MS ElBohy, M.Sc

  Future University in Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer assisstant

Study Record Dates

• First Submitted: January 12, 2019
• First Posted: January 23, 2019
• Study Start: January 5, 2016
• Primary Completion: December 10, 2016
• Study Completion: December 30, 2016
• Last Updated: January 24, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share