Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00475059

Enrollment

Registered

2007-05-17

Start date

2007-03-31

Completion date

2008-03-31

Last updated

2010-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

kidney transplantation, Glomerular filtration rate, inulin clearance, MDRD equation, cystatin C, cimetidine

Brief summary

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.

Interventions

DRUGcimetidine arrow

patients who received cimétidine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
performance of inulin clearance and MDRD with or no block of secretion renal tubule with cimetidine	two days

Secondary

Measure	Time frame
Performance of different prediction equations for estimating renal function with or no block of secretion renal tubule with cimetidine : - Walser equation - Nankivell equation - Cockcroft and Gault equation	two days
comparison between inulin clearance and cystatin C	two days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026