Overview

Influence of Aliskiren on Albuminuria After Kidney Transplantation

Status:
Completed

Trial end date:
2014-11-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Medical University of Gdansk

Treatments:

Losartan

Criteria

Inclusion Criteria:

1. Transplantation period above 6 months,

2. Calcineurin inhibitor (cyclosporine or tacrolimus) based immunosuppression,

3. Stable cyclosporine or tacrolimus trough level in the last three months (no variations
above 25%),

4. Stable renal function defined as eGFR > 30 ml/min (no variations above 5 ml/min/1.73
m2 in the last 3 months),

5. Arterial hypertension treated with one or two antihypertensive agents or blood
pressure (BP) > 130/80 mmHg in patients not treated yet,

6. Albuminuria > 30 mg/g creatinine.

Exclusion Criteria:

1. Pregnant or the possibility of becoming so and breast feeding.

2. Angioedema from an ACE inhibitor or ARA in the history.

3. Serum potassium greater than 5.5 mmol/l on two or more occasions in the preceding
three months.

4. Graft artery stenosis (i.e. psv of more than 200 cm/s in doppler usg)

5. Left ventricular dysfunction that requires an ACE inhibitor or an ARA Protocol Version
1 p. 5 of 10

6. New immunosuppressive agent was started or previous immunosuppressant stopped in the
three months prior to study entry or plan to switch immunosuppressive agents within
next three months.

7. Currently on four or more blood pressure pills and have an average blood pressure over
three visits greater than 150/100.

8. Currently on an ACE-inhibitor or an ARAor treatment with an ACE inhibitor or ARA after
kidney transplantation lasted more than 3 months.

9. Had an acute coronary syndrome, episode of malignant hypertension, stroke or transient
ischaemic attack in the three months prior to study entry