Clinical Trial: Influence of Aliskiren on Albuminuria After Kidney Transplantation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Influence of Aliskiren on Albuminuria After Kidney Transplantation

Brief 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 Summary: 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.
Sponsor: Medical University of Gdansk

Current Primary Outcome: a difference in albuminuria in the measurements available for each patient [ Time Frame: after 8 weeks of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • a differences in N-acetyl-β-D-glucosaminidase (NAG) urine excretion in the measurements available for each patient [ Time Frame: after 8 weeks of treatment ]
  • a differences in transforming growth factor β-1 (TGF-β-1) urine excretion in the measurements available for each patient [ Time Frame: after 8 weeks of treatment ]
  • a differences in 15-F2t-isoprostanes (isoprostanes) urine excretion in the measurements available for each patient [ Time Frame: after 8 weeks of treatment ]


Original Secondary Outcome: Same as current

Information By: Medical University of Gdansk

Dates:
Date Received: May 8, 2015
Date Started: March 2013
Date Completion:
Last Updated: May 13, 2015
Last Verified: May 2015