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Randomized Controlled Trial
. 2015 Jan;26(1):220-9.
doi: 10.1681/ASN.2014010012. Epub 2014 Jun 26.

Effect of pentoxifylline on renal function and urinary albumin excretion in patients with diabetic kidney disease: the PREDIAN trial

Juan F Navarro-González  1 , Carmen Mora-Fernández  2 , Mercedes Muros de Fuentes  3 , Jesús Chahin  4 , María L Méndez  4 , Eduardo Gallego  4 , Manuel Macía  4 , Nieves del Castillo  4 , Antonio Rivero  4 , María A Getino  4 , Patricia García  4 , Ana Jarque  4 , Javier García  4
Affiliations
Randomized Controlled Trial

Effect of pentoxifylline on renal function and urinary albumin excretion in patients with diabetic kidney disease: the PREDIAN trial

Juan F Navarro-González et al. J Am Soc Nephrol. 2015 Jan.

Abstract

Diabetic kidney disease (DKD) is the leading cause of ESRD. We conducted an open-label, prospective, randomized trial to determine whether pentoxifylline (PTF), which reduces albuminuria, in addition to renin-angiotensin system (RAS) blockade, can slow progression of renal disease in patients with type 2 diabetes and stages 3-4 CKD. Participants were assigned to receive PTF (1200 mg/d) (n=82) or to a control group (n=87) for 2 years. All patients received similar doses of RAS inhibitors. At study end, eGFR had decreased by a mean±SEM of 2.1±0.4 ml/min per 1.73 m(2) in the PTF group compared with 6.5±0.4 ml/min per 1.73 m(2) in the control group, with a between-group difference of 4.3 ml/min per 1.73 m(2) (95% confidence interval [95% CI], 3.1 to 5.5 ml/min per 1.73 m(2); P<0.001) in favor of PTF. The proportion of patients with a rate of eGFR decline greater than the median rate of decline (0.16 ml/min per 1.73 m(2) per month) was lower in the PTF group than in the control group (33.3% versus 68.2%; P<0.001). Percentage change in urinary albumin excretion was 5.7% (95% CI, -0.3% to 11.1%) in the control group and -14.9% (95% CI, -20.4% to -9.4%) in the PTF group (P=0.001). Urine TNF-α decreased from a median 16 ng/g (interquartile range, 11-20.1 ng/g) to 14.3 ng/g (interquartile range, 9.2-18.4 ng/g) in the PTF group (P<0.01), with no changes in the control group. In this population, addition of PTF to RAS inhibitors resulted in a smaller decrease in eGFR and a greater reduction of residual albuminuria.

Keywords: albuminuria; chronic kidney disease; diabetic nephropathy; inflammation; progression of chronic renal failure.

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Figures

Figure 1.
Figure 1.
Flow diagram of participants in the study.
Figure 2.
Figure 2.
Evolution of average systolic and diastolic BP at randomization (basal) and during follow-up in the control and PTF groups without any significant difference between groups.
Figure 3.
Figure 3.
Evolution of the mean eGFR at randomization (basal) and during follow-up in the control and PTF groups. Difference of the mean eGFR between groups show statistical significance after 24 months of follow-up. Vertical bars represent the SD. P values are for the comparison of the PTF group versus the control group.
Figure 4.
Figure 4.
Change in eGFR and UAE from baseline to the end of the study. Patients in the control group presented a significantly higher reduction of UAE and a lower decrease in the eGFR. Vertical bars represent 95% CIs. P values are for the comparison of the PTF group versus the control group.
Figure 5.
Figure 5.
Percentage of patients with an eGFR reduction greater than the median decline observed in the overall group and >25% with regard to baseline according to study group. In both cases, the percentage of subjects was significantly lower in the PTF group. P values are for the comparison between groups.
See this image and copyright information in PMC

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