NCT02446548

Influence of Aliskiren on Albuminuria After Kidney Transplantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Medical University of Gdansk · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Albuminuria

Interventions

Type	Name	Description
DRUG	aliskiren	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.
DRUG	losartan	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.
OTHER	Placebo	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

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-04-01
• Completion: 2014-11-01
• First posted: 2015-05-18
• Last updated: 2015-05-18

Locations

1 site across 1 country: Poland