Aliskiren reduces albuminuria after kidney transplantation.
Tylicki L, Debska-Slizien AM, et al.Acta Biochimica Polonica 2017; 64(2): 221-226.
Aims
To evaluate the influence of aliskiren on albuminuria and other surrogate markers of kidney injury in patients after renal transplantation.
Interventions
All participants completed an 8 week run-in period, followed by 8 weeks of active treatment, an 8-week placebo-washout (W) and 8 weeks of active treatment with the alternative medication. Participants were randomly allocated to one of two treatment sequences, losartan (L)/W/aliskiren (A), versus A/W/L.
Participants
16 renal transplant recipients > 6 months posttransplant with stable renal function, arterial hypertension and albuminuria > 30 mg/g creatinine.
Outcomes
The primary outcome measured was the difference in the ratio of albumin to creatinine. The secondary outcome was the presence of differences in N-acetyl-β-D-glucosaminidase, transforming growth factor β-1 and isoprostanes urine excretion.
Follow-up
8 weeks
CET Conclusions
This study report details good quality markers such as appropriate randomisation method and double blinding. Unfortunately, it was a very small study (16 in per protocol analysis, no power calculation), albeit the first controlled study of aliskiren in renal transplant patients. Both aliskiren 50mg and losartan 150mg reduced urine albumin:creatinine ratio similarly, with similar reductions in 24H systolic and diastolic blood pressure. Losartan decreased secretion of N-acetyl-Beta-D-glucosaminidase (NAG) in the urine more effectively. Renal function and serum potassium levels remained stable during the follow up period, although it was only 8 weeks for each treatment phase. The ALTITUDE study of aliskiren was halted early (Parving et al 2012), with a median follow up of nearly 3 years and included 8561 patients. The ALTITUDE study prompted the FDA to recommend that aliskiren not be used with other Renin-Angiotensin-Aldosterone System inhibiting agents in patients with diabetes or moderate to severe renal impairment. I am therefore very cautious about extrapolating from the results presented by Tylicki et al.
Data analysis
Per protocol analysis
Trial registration
None