|
Welcome
|
|
21 March 2013
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Effect of spironolactone on ischemia reperfusion injury in renal transplant recipients |
| ISRCTN | ISRCTN01577227 |
| DOI | 10.1186/ISRCTN01577227 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Effect of spironolactone on ischemia reperfusion injury in renal transplant recipients |
| Scientific title | Effect of mineralocorticoid receptor blockade on ischemia / reperfusion injury in renal transplant recipients: A pilot study |
| Acronym | N/A |
| Serial number at source | REF 421 |
| Study hypothesis | Spironolactone reduces the tubular damage and oxidative stress in renal transplant patients from living donor. |
| Lay summary |
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 |
| Ethics approval | Ethical Committee of National Institute of Medical Sciences and Nutrition (Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran), January 2012, Ref 421 |
| Study design | Double-blind randomized placebo-controlled clinical pilot study |
| Countries of recruitment | Mexico |
| Disease/condition/study domain | Ischemia reperfusion injury |
| Participants - inclusion criteria |
1. Age of 18 years or older, male and female
2. Receipt of a live-donor kidney |
| Participants - exclusion criteria |
1. Multi-organ transplant
2. Deceased-donor kidney 3. Induction with thymoglobuline |
| Anticipated start date | 01/01/2013 |
| Anticipated end date | 01/05/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 60 |
| Interventions | 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. |
| 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. |
| 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 |
| Sources of funding | Health Sector Grant from Mexican Council of Science and Technology (Fondo Sectorial Salud 2012) (Mexico) Project: SALUD-2012-01-181267 |
| Trial website | |
| Publications | |
| Contact name | Dr Norma A Bobadilla |
| Address |
Vasco de Quiroga no.
15 Col. Sección XVI |
| City/town | D.F |
| Zip/Postcode | 14000 |
| Country | Mexico |
| Tel | +52 (0) 555 5485-2676 |
| Fax | +52 (0) 555 5655-0382 |
| norma.bobadillas@quetzal.innsz.mx | |
| Sponsor | Mexican Council of Science and Technology (Consejo Nacional de Ciencia y Tecnología CONACyT) (Mexico) |
| Address |
Av. Insurgentes Sur 1582
Col. Crédito Constructor Del. Benito Juárez C.P.: 03940 |
| City/town | Mexico DF |
| Zip/Postcode | - |
| Country | Mexico |
| Tel | +52 (0) 555 5322-7700 |
| carcer@conacyt.mx | |
| Date applied | 17/12/2012 |
| Last edited | 23/01/2013 |
| Date ISRCTN assigned | 23/01/2013 |
|
|
|
|
|
| © 2013 ISRCTN unless otherwise stated. | |
|
