Influence of Aliskiren on Albuminuria After Kidney Transplantation
Condition: Albuminuria
MeSH terms: Albuminuria
Study type: Interventional

Summary: 
      The study is a randomised, double-blind, controlled 2 x 3 cross-over trial in which the renal
      effects of therapy with aliskiren (A), placebo (P) and losartan (L) will be compared. It
      consists of an 8-week run-in period, 8 weeks of active treatment with aliskiren or losartan
      (period 1), 8 weeks of active treatment with the alternative medication (period 2), and an
      8-week placebo administration between them.
    

Detailed description: 
      At the beginning, subjects who met the inclusion criteria will enter the 8-week run-in
      screening period. All hypotensive group of drugs will be allowed with exception of ACEI, ARA,
      DRI and mineralocorticoid receptor antagonists. The target BP will be an office trough BP of
      140/90 mmHg or less. At the end of the run-in period, patients will be randomly allocated to
      one of the two treatment sequences: L/P/A (sequence 1) or A/P/L (sequence 2) . The study
      medications will be introduced as single hypotensive drug or added to the current hypotensive
      agents, the dosage of which, once adjusted in the run-in period, will be left unchanged
      throughout the study. Losartan will be used at a dose of 50 mg and aliskiren will be
      administered at a dose of 150 mg. Drug compliance will be assessed by tablet counts. Patients
      will be recommended not to change their usual daily protein and sodium intake during the
      study period. Dosage of cyclosporine or tacrolimus will be not allowed to change either. At
      the end of each of the three treatment periods, office thorough BP, 24-h ambulatory BP,
      albuminuria, serum creatinine and potassium, haemoglobin, cyclosporine or tacrolimus level,
      urine excretion of NAG, TGF-β-1 and 15-F2t-isoprostanes will be determined. eGFR will be
      calculated. Patients will be also asked to fill in the questionnaire for measuring
      patients-reported side effects.
    

Intervention name(s): aliskiren; losartan; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): aliskiren will be administered at a dose of 150 mg, each dose was to be taken orally with water once daily at approximately 8:00 A.M., except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed. Drug compliance will be assessed by tablet counts.; losartan will be administered at a dose of 50 mg, each dose was to be taken orally with water once daily at approximately 8:00 A.M. except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed. Drug compliance will be assessed by tablet counts.; placebo will be administered once daily orally (1 tablet) in the morning with water at approximately 8:00 A.M. except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed. Compliance will be assessed by tablet counts. Placebo was prapared in Department of Pharmaceutical Technology MU Gdańsk
Other intervention name(s): Rasilez (Novarits Europe); Xartan (Adamed, Poland)
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: direct renin inhibitor; kidney transplantation; albuminuria