Influence of Aliskiren on Albuminuria After Kidney Transplantation
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 8, 2015
CompletedFirst Posted
Study publicly available on registry
May 18, 2015
CompletedMay 18, 2015
May 1, 2015
1.1 years
May 8, 2015
May 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
a difference in albuminuria in the measurements available for each patient
after 8 weeks of treatment
Secondary Outcomes (3)
a differences in N-acetyl-β-D-glucosaminidase (NAG) urine excretion in the measurements available for each patient
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
after 8 weeks of treatment
a differences in 15-F2t-isoprostanes (isoprostanes) urine excretion in the measurements available for each patient
after 8 weeks of treatment
Study Arms (2)
aliskiren - placebo - losartan
EXPERIMENTALaliskiren (Rasilez) 150 mg; losartan (Xartan) 50 mg
losartan - placebo - aliskiren
EXPERIMENTALaliskiren (Rasilez) 150 mg; losartan (Xartan) 50 mg
Interventions
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
Eligibility Criteria
You may qualify if:
- Transplantation period above 6 months,
- Calcineurin inhibitor (cyclosporine or tacrolimus) based immunosuppression,
- Stable cyclosporine or tacrolimus trough level in the last three months (no variations above 25%),
- Stable renal function defined as eGFR \> 30 ml/min (no variations above 5 ml/min/1.73 m2 in the last 3 months),
- Arterial hypertension treated with one or two antihypertensive agents or blood pressure (BP) \> 130/80 mmHg in patients not treated yet,
- Albuminuria \> 30 mg/g creatinine.
You may not qualify if:
- Pregnant or the possibility of becoming so and breast feeding.
- Angioedema from an ACE inhibitor or ARA in the history.
- Serum potassium greater than 5.5 mmol/l on two or more occasions in the preceding three months.
- Graft artery stenosis (i.e. psv of more than 200 cm/s in doppler usg)
- Left ventricular dysfunction that requires an ACE inhibitor or an ARA Protocol Version 1 p. 5 of 10
- 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.
- Currently on four or more blood pressure pills and have an average blood pressure over three visits greater than 150/100.
- Currently on an ACE-inhibitor or an ARAor treatment with an ACE inhibitor or ARA after kidney transplantation lasted more than 3 months.
- Had an acute coronary syndrome, episode of malignant hypertension, stroke or transient ischaemic attack in the three months prior to study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Gdansk
Gdansk, Pomeranian Voivodeship, 80-211, Poland
Related Publications (1)
Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.
PMID: 39082471DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Boleslaw Rutkowski, Prof.
Deaprtment of Nephrology, Transplantology and Internal Medicine, Medical University of Gdansk
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 8, 2015
First Posted
May 18, 2015
Study Start
March 1, 2013
Primary Completion
April 1, 2014
Study Completion
November 1, 2014
Last Updated
May 18, 2015
Record last verified: 2015-05