Phase 4 Completed N=30 Randomized Prevention

Cytokines Evaluation in Early Calcineurin Inhibitors Withdrawn on Renal Transplant

Renal Transplant Rejection · Immunosuppression

Source: ClinicalTrials.gov NCT01239472 ↗

Enrolled (actual)

Serious AEs

3.3%

Results posted

Oct 2019

Primary outcomePrimary: Cytokines Evaluation — 380; 893; 763; 147 MFI — p=<0.05

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

Currently, acute kidney injury is diagnosed by increased serum creatinine. However, creatinine is not a reliable marker for acute changes in renal function. The biology of the renal graft is influenced by chemokines from reperfusion (just after the kidney transplant) and throughout its course, when acute and chronic inflammatory changes occurs. Moreover, the evaluation of changes in urinary cytokines reflects kidney interstitial patterns, and can predict renal function, acute rejection episodes and their response to treatment. Today there are several studies comparing the relative immunosuppression of renal function, but few noticed its relationship with cytokines and chemokines. Thus, we proposed studying the inflammatory consequences of early calcineurin inhibitors (ICN) withdrawing in transplant patients by urine analysis. Kidney biopsy was done before ICN withdrawn and replaced by everolimus (3 months after transplant), and 1 year after transplant.

Outcome Measures

Outcome	Result	p-value
PRIMARY Cytokines Evaluation	380; 893; 763; 147; 2349; 4119	<0.05 sig
SECONDARY Evaluation of Renal Function	1.6; 1.3; 1.4; 1.4	<0.05 sig

Eligibility Criteria

Inclusion Criteria

Patients over 18 years old and under 65 years old
Recipients of first kidney transplant
Donor younger than 65 years old
PRA (panel reactive antigen) ≤ 30% in class I or class II
No acute rejection episodes
Proteinuria <1000 mg / day

Exclusion Criteria

multiple organ transplant recipient
Chronic liver failure
Asymptomatic bacteriuria or urinary infection at randomization time
Creatinine ≥ 2 mg / dL at randomization time (90 days after transplant)
Presence of uncontrolled hypercholesterolemia (≥ 350 mg / dL, ≥ 9.1 mmol / L) or hypertriglyceridemia (≥ 500 mg / dL, ≥ 5.6 mmol / L) at randomization time (90 days after transplant)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01239472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.