AzTrials
AzTrials

Renal TransplantRETASKNCT03317925

Renal Transplant Injury and the Renin-Angiotensin System in Kids (RETASK)

An observational study of Renal Transplant and Renin-Angiotensin System, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In pediatric kidney transplant patients, rejection, medication toxicity and ischemia cause early and chronic renal allograft injury, which reduces graft lifespan and patient survival. Early detection of injury would facilitate prevention and treatment. Read more about this study

Who is it for?
Ages 1 year to 20 years
What is being tested?
Renal Transplantation
Type of treatment
Surgery or procedure
How many people
29 participants
Where
1 siteUnited States
Study dates
16 Jul 2014to 26 Apr 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: This is an observational study with a convenience sample of patients recruited from Lucile Packard Children's Hospital kidney transplant evaluation clinic.

Who may be able to join

  • Ages 1 - 20 years
  • Actively listed on the transplant list at Lucile Packard Children's Hospital at Stanford and received a renal transplant during the study enrollment period

Who cannot join

  • Transplanted at a center other than Lucile Packard Children's Hospital at Stanford

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

In pediatric kidney transplant patients, rejection, medication toxicity and ischemia cause early and chronic renal allograft injury, which reduces graft lifespan and patient survival. Early detection of injury would facilitate prevention and treatment. The gold standard surveillance biopsy has limitations including delayed discovery of injury. No noninvasive test identifies graft injury before it is clinically apparent. This project's goal is to develop a novel early marker of subclinical graft injury to facilitate prompt recognition and treatment.

Read the detailed description

Kidney damage activates the traditional renin-angiotensin (Ang) system (RAS), characterized by Ang-converting enzyme (ACE)/Ang II/Ang II type 1 receptor. The Ang-converting enzyme 2 (ACE2)/Ang-(1-7)/Mas pathway counteracts this damage. The balance, or ratio, between levels of the ACE/Ang II and ACE2/Ang-(1-7) pathways may be clinically important because Ang-(1-7) counteracts Ang II-mediated injury. An increase in ACE and Ang II expression and a decrease in ACE2 and Ang-(1-7) expression on tubular cells may promote renal injury. Tubular damage may increase urinary loss of protective ACE2 and Ang-(1-7), propagating renal damage by allowing ACE and Ang II to stimulate inflammation and fibrosis unopposed. The investigators hypothesis is that a shift in the urinary ACE-to-ACE2 and Ang II-to-Ang-(1-7) ratios towards ACE2 and Ang-(1-7) predicts acute graft injury diagnosed on renal biopsy and predicts chronic graft damage on renal biopsy.

Being tested
Renal Transplantation
Keywords
Pediatric Renal Transplant, Renal Allograft, Angiotensin II, Angiotensin-(1-7), ACE, ACE2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Renal TransplantationProcedure or surgery

    Kidney transplantation and biomarkers that can identify injury after transplant.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute graft injury

    Renal biopsy-confirmed acute renal allograft injury as determined by a pathologist (binary yes or no)

    Measured: Within six months after kidney transplant

Secondary outcomes (3)

  1. Chronic graft damage

    Renal biopsy-confirmed chronic renal allograft damage as determined by a quantitative fibrosis pathology stain (percent fibrosis from 0 to 100%)

    Measured: Six months after kidney transplant

  2. Renal function

    Glomerular filtration rate by the Schwartz equation (mL/min/1.73 m^2)

    Measured: Within six months after kidney transplant

  3. Proteinuria

    Urine protein-to-creatinine ratio above 0.2 mg/mg creatinine

    Measured: Within six months after kidney transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2017
  2. Study start16 Jul 2014
  3. Primary completion20 Jan 2016
  4. Study completion26 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03317925
Sponsor's protocol ID
00046001
Acronym
RETASK
Status last verified
Oct 2017
First submitted
18 Oct 2017
Last updated
8 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Furness PN, Taub N, Assmann KJ, Banfi G, Cosyns JP, Dorman AM, Hill CM, Kapper SK, Waldherr R, Laurinavicius A, Marcussen N, Martins AP, Nogueira M, Regele H, Seron D, Carrera M, Sund S, Taskinen EI, Paavonen T, Tihomirova T, Rosenthal R. International variation in histologic grading is large, and persistent feedback does not improve reproducibility. Am J Surg Pathol. 2003 Jun;27(6):805-10. doi: 10.1097/00000478-200306000-00012.

    PubMed 12766585

  • Solez K, Colvin RB, Racusen LC, Haas M, Sis B, Mengel M, Halloran PF, Baldwin W, Banfi G, Collins AB, Cosio F, David DS, Drachenberg C, Einecke G, Fogo AB, Gibson IW, Glotz D, Iskandar SS, Kraus E, Lerut E, Mannon RB, Mihatsch M, Nankivell BJ, Nickeleit V, Papadimitriou JC, Randhawa P, Regele H, Renaudin K, Roberts I, Seron D, Smith RN, Valente M. Banff 07 classification of renal allograft pathology: updates and future directions. Am J Transplant. 2008 Apr;8(4):753-60. doi: 10.1111/j.1600-6143.2008.02159.x. Epub 2008 Feb 19.

    PubMed 18294345

  • Halawa A. The early diagnosis of acute renal graft dysfunction: a challenge we face. The role of novel biomarkers. Ann Transplant. 2011 Jan-Mar;16(1):90-8.

    PubMed 21436782

  • Hall IE, Yarlagadda SG, Coca SG, Wang Z, Doshi M, Devarajan P, Han WK, Marcus RJ, Parikh CR. IL-18 and urinary NGAL predict dialysis and graft recovery after kidney transplantation. J Am Soc Nephrol. 2010 Jan;21(1):189-97. doi: 10.1681/ASN.2009030264. Epub 2009 Sep 17.

    PubMed 19762491

  • Schaub S, Mayr M, Honger G, Bestland J, Steiger J, Regeniter A, Mihatsch MJ, Wilkins JA, Rush D, Nickerson P. Detection of subclinical tubular injury after renal transplantation: comparison of urine protein analysis with allograft histopathology. Transplantation. 2007 Jul 15;84(1):104-12. doi: 10.1097/01.tp.0000268808.39401.e8.

    PubMed 17627245

  • Ruster C, Wolf G. Renin-angiotensin-aldosterone system and progression of renal disease. J Am Soc Nephrol. 2006 Nov;17(11):2985-91. doi: 10.1681/ASN.2006040356. Epub 2006 Oct 11.

    PubMed 17035613

  • Iwai M, Horiuchi M. Devil and angel in the renin-angiotensin system: ACE-angiotensin II-AT1 receptor axis vs. ACE2-angiotensin-(1-7)-Mas receptor axis. Hypertens Res. 2009 Jul;32(7):533-6. doi: 10.1038/hr.2009.74. Epub 2009 May 22.

    PubMed 19461648

  • Ferrario CM. ACE2: more of Ang-(1-7) or less Ang II? Curr Opin Nephrol Hypertens. 2011 Jan;20(1):1-6. doi: 10.1097/MNH.0b013e3283406f57.

    PubMed 21045683

  • Santos RA, Ferreira AJ, Pinheiro SV, Sampaio WO, Touyz R, Campagnole-Santos MJ. Angiotensin-(1-7) and its receptor as a potential targets for new cardiovascular drugs. Expert Opin Investig Drugs. 2005 Aug;14(8):1019-31. doi: 10.1517/13543784.14.8.1019.

    PubMed 16050794

  • Santos RA, Ferreira AJ, Simoes E Silva AC. Recent advances in the angiotensin-converting enzyme 2-angiotensin(1-7)-Mas axis. Exp Physiol. 2008 May;93(5):519-27. doi: 10.1113/expphysiol.2008.042002. Epub 2008 Feb 29.

    PubMed 18310257

  • Dilauro M, Burns KD. Angiotensin-(1-7) and its effects in the kidney. ScientificWorldJournal. 2009 Jun 30;9:522-35. doi: 10.1100/tsw.2009.70.

    PubMed 19578709

  • Heringer-Walther S, Eckert K, Schumacher SM, Uharek L, Wulf-Goldenberg A, Gembardt F, Fichtner I, Schultheiss HP, Rodgers K, Walther T. Angiotensin-(1-7) stimulates hematopoietic progenitor cells in vitro and in vivo. Haematologica. 2009 Jun;94(6):857-60. doi: 10.3324/haematol.2008.000034. Epub 2009 Apr 18.

    PubMed 19377080

  • Geara AS, Azzi J, Jurewicz M, Abdi R. The renin-angiotensin system: an old, newly discovered player in immunoregulation. Transplant Rev (Orlando). 2009 Jul;23(3):151-8. doi: 10.1016/j.trre.2009.04.002.

    PubMed 19539879

  • Miyake-Ogawa C, Miyazaki M, Abe K, Harada T, Ozono Y, Sakai H, Koji T, Kohno S. Tissue-specific expression of renin-angiotensin system components in IgA nephropathy. Am J Nephrol. 2005 Jan-Feb;25(1):1-12. doi: 10.1159/000083224. Epub 2005 Jan 7.

    PubMed 15644622

  • Jurewicz M, McDermott DH, Sechler JM, Tinckam K, Takakura A, Carpenter CB, Milford E, Abdi R. Human T and natural killer cells possess a functional renin-angiotensin system: further mechanisms of angiotensin II-induced inflammation. J Am Soc Nephrol. 2007 Apr;18(4):1093-102. doi: 10.1681/ASN.2006070707. Epub 2007 Feb 28.

    PubMed 17329576

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Transplant and Renin-Angiotensin System, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute graft injury (time frame: Within six months after kidney transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03317925, which also lists 45 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in