Effect of spironolactone on ischemia reperfusion injury in renal transplant recipients
| ISRCTN | ISRCTN01577227 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01577227 |
| Secondary identifying numbers | REF 421 |
- Submission date
- 17/12/2012
- Registration date
- 23/01/2013
- Last edited
- 23/01/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Ischemia and reperfusion processes are the major causes of acute kidney injury in patients receiving real tissues from a donor (this is called a renal allograft). This leads to different degrees of early post-transplant renal dysfunction. Aldosterone is a traditional treatment but has disadvantages. The aim of the study is to assess whether giving another drug called Spironolactone before and after renal transplant rom living donors decreases renal damage caused by ischemia/reperfusion
Who can participate?
You may participate if you are a patient in hemodialysis or peritoneal dialysis and you will receive a renal allograft from a living donor, you are at least 18 years old, you are male or female, you are compatible with your donor
You cannot enter this study if you receive two or more organs simultaneously and if you receive allograft from a deceased donor.
What does the study involve?
Participants will be randomly allocated to one of three groups of treatment (Spironolactone 50 mg, Spironolactone 100 mg or dummy). All treatments looks identical (1 capsule). Neither you nor your doctors will be able to know or decide which group you are in. You will take the capsule twice a day, three days before transplant surgery and five days after your surgery. The doctors will ask your permission to get a sample of blood and urine before transplant surgery and at days 1, 5 after transplant. They will use the samples to carry out routine laboratory tests in the laboratory that may help them to compare renal function recovery and biomarkers of renal injury. At day five after your surgery your participation will be completed.
What are the possible benefits and risks of participating?
The most common side effect of spironolactone is hyperkalemia (high level of serum potassium).
Where is the study run from?
This study will recruit 60 patients a year from the Transplant Department at Instituto Nacional de Ciencias Médicas Salvador Zubiran in México City, Hospital General de Mexico and
Centro Médico Nacional Siglo XXI.
When is the study starting and how long is it expected to run for?
From January 2013 to .May 2014.
Who is funding the study?
Mexican Council of Science and Technology and National University of Mexico grants.
Who is the main contact?
Dr Luis E. Morales-Buenrostro
Dr Norma A. Bobadilla, norma.bobadillas@quetzal.innsz.mx
Contact information
Scientific
Vasco de Quiroga no.
15 Col. Sección XVI
D.F
14000
Mexico
| Phone | +52 (0) 555 5485-2676 |
|---|---|
| norma.bobadillas@quetzal.innsz.mx |
Study information
| Study design | Double-blind randomized placebo-controlled clinical pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of mineralocorticoid receptor blockade on ischemia / reperfusion injury in renal transplant recipients: A pilot study |
| Study objectives | Spironolactone reduces the tubular damage and oxidative stress in renal transplant patients from living donor. |
| Ethics approval(s) | Ethical Committee of National Institute of Medical Sciences and Nutrition (Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran), January 2012, Ref 421 |
| Health condition(s) or problem(s) studied | Ischemia reperfusion injury |
| Intervention | The patients will be randomized to receive 50 or 100 mg of spironolactone (Sp) or placebo orally twice daily (BID), 3 days prior to transplant surgery and 50 or 100 mg of Sp or placebo orally BID during three consecutive days after transplantation. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Spironolactone |
| Primary outcome measure | Reduction of urinary biomarkers of kidney injury [ Heat shock protein 72 (HsP72), Interleukin-18 (IL-18), kidney injury molecule-1 (KIM-1)] at baseline, day 1, and 5 post transplantation. |
| Secondary outcome measures | 1. Reduction of oxidative stress 2. Change in urinary hydrogen peroxide excretion 3. Change in urinary nitrates excretion All measures at baseline, day 1, and 5 post transplantation |
| Overall study start date | 01/01/2013 |
| Completion date | 01/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Age of 18 years or older, male and female 2. Receipt of a live-donor kidney |
| Key exclusion criteria | 1. Multi-organ transplant 2. Deceased-donor kidney 3. Induction with thymoglobuline |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 01/05/2014 |
Locations
Countries of recruitment
- Mexico
Study participating centre
14000
Mexico
Sponsor information
University/education
Av. Insurgentes Sur 1582
Col. Crédito Constructor Del.
Benito Juárez C.P.: 03940
Mexico DF
-
Mexico
| Phone | +52 (0) 555 5322-7700 |
|---|---|
| carcer@conacyt.mx | |
"ROR" |
https://ror.org/059ex5q34 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
