Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Kidney Transplantation

Treatments: Drug: cimetidine arrow

Study type: Interventional

Funder types: Other

Identifiers

NCT00475059

2006-005294-22

0608090

Details and patient eligibility

About

Among the different creatinine-based GFR predicting equations, the MDRD equation gives the best prediction in renal transplantation but does not provide the level of accuracy usually seen in renal patients with native kidneys.

Blocking the tubular secretion of creatinine with an oral administration of cimetidine is likely to make creatinine a more accurate marker of GFR.

We will test the hypothesis that the accuracy of the MDRD equation will be improved in renal transplant patients by incorporating into the equation a cimetidine-corrected serum creatinine value.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Kidney transplantation > 1 year
• Patient with immunosuppressant treatment of TACROLIMUS (PROGRAF)
• Creatinine clearance > 30 ml/min/1,73m2 within 3 months before inclusion
• Written informed consent
• Patient affiliated to social insurance

Exclusion criteria

• Unstable renal function defined by serum creatinine (J0) > 25% serum creatinine realised in 3 months
• Treatment: Bactrim, Fansidar, Cimetidine arrow within the week before inclusion
• Contraindication listed in the labeling of Cimetidine arrow
• Last residual rate of Tacrolimus > 12 ng/ml.
• Treatment : carvedilol, phenytoïn (interaction with cimetidine)
• Serious hepatic insufficiency

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

59 participants in 1 patient group

1

Experimental group

Description:

patients who received cimétidine

Treatment:

Drug: cimetidine arrow