Assessment of the use of spironolactone on the endothelial glycocalyx in patients with kidney transplants

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000966493

Acronym

ASGARD

Enrollment

Registered

2016-07-22

Start date

2016-08-05

Completion date

2017-01-23

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The glycocalyx is a particle that is important in maintaining blood vessel health. Patients with kidney disease have impaired blood vessel function, and previous studies have indicated that the glycocalyx is affected in those who have kidney disease. Laboratory studies indicate that the use of spironolactone, a common medication used for blood pressure, heart failure and to reduce protein in the urine, can have beneficial effects on the glycocalyx. The purpose of this study is to assess if the glycocalyx is affected in people who have kidney transplants, and whether spironolactone has any additional protective benefits on the glycocalyx.

Interventions

Spironolactone 25mg, oral tablet, once daily for 2 months. Adherence to be monitored by questionnaire and return of empty drug packets. Wash-out period of 1 month. Then crossover to standard-of-care for 2 months (total trial period of 5 months).

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Kidney transplant >1 year ago

Exclusion criteria

Malignancy, pregnancy, inability to consent, known haematological disorders, serum potassium > 5.0 mmol/L

Outcome results