Effect of spironolactone on ischemia reperfusion injury in renal transplant recipients

ISRCTN	ISRCTN01577227
DOI	https://doi.org/10.1186/ISRCTN01577227
Protocol serial number	REF 421
Sponsor	Mexican Council of Science and Technology (Consejo Nacional de Ciencia y Tecnología CONACyT) (Mexico)
Funder	Health Sector Grant from Mexican Council of Science and Technology (Fondo Sectorial Salud 2012) (Mexico) Project: SALUD-2012-01-181267

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Norma A Bobadilla
Scientific

Vasco de Quiroga no.
15 Col. Sección XVI
D.F
14000
Mexico

Phone	+52 (0) 555 5485-2676
Email	norma.bobadillas@quetzal.innsz.mx

Study information

Primary study design	Interventional
Study design	Double-blind randomized placebo-controlled clinical pilot study
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Spironolactone
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/05/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Vasco de Quiroga no.

D.F
14000
Mexico

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes