Complications of Renal Transplant
Conditions
Keywords
cardiovascular disease, kidney transplantation
Brief summary
Cardiovascular disease is the leading cause of mortality in kidney transplantation. The enzyme xanthine oxidase may play an important role in the cardiovascular disease of kidney transplant recipients. Inhibiting this enzyme with allopurinol may improve vascular health and protects against cardiovascular complications.
Detailed description
This is a prospective, double-blind, placebo controlled, clinical trial examining vascular effects of allopurinol in patients who received a kidney transplant that are maintaining stable renal function for at least 1 year. End-points include pulse-wave velocity, systemic blood pressure and kidney function among others.
Interventions
DRUGallopurinol or placebo
Daily active drug (allopurinol administered orally) administered orally for 3 years.
OTHERPlacebo
Sugar pill administered orally for 3 years.
Sponsors
Roberto S Kalil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* age 18 years or older * both genders * recipients of living donor or deceased-donor kidney transplant with stable renal function
Exclusion criteria
* history of gout * allergy to allopurinol * use of azathioprine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Events | 3 years | Number of major cardiovascular events |
| Endothelial Function | 3 years | Changes in flow-mediated dilatation of braquial artery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial Stiffness | 3 years | Changes in pulse wave velocity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Allopurinol allopurinol or placebo: Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years. | 10 |
| Placebo (Sugar Pill) allopurinol or placebo: Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years. | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Insufficient funding | 10 | 10 |
Baseline characteristics
| Characteristic | Allopurinol | Placebo (Sugar Pill) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Cardiovascular Events
Number of major cardiovascular events
Time frame: 3 years
Population: No intervention occurred, so no data was collected for report.
Primary
Endothelial Function
Changes in flow-mediated dilatation of braquial artery.
Time frame: 3 years
Population: No intervention occurred, so no data was collected for report.
Secondary
Arterial Stiffness
Changes in pulse wave velocity.
Time frame: 3 years
Population: No intervention occurred, so no data was collected for report.