Overview

Esomeprazole or Pantoprazole in Renal Transplantation

Status:
Completed
Trial end date:
2016-12-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Future University in Egypt
Collaborators:
Ain Shams University
Nasser Institute For Research and Treatment
Treatments:
Cyclosporine
Cyclosporins
Esomeprazole
Pantoprazole
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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