Effects of Endothelin Receptor Antagonist on Ischemic Kidney Injury During Nephron Sparing Surgery

NCT04450095 | Unknown Phase 2

• 1 other identifier: 0048-18-BNZ
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Based on animal studies, it was found that administration of endothelial receptor antagonists before and after renal blood vessels clamp and release results in a significantly reduced renal function injury. On the basis of these results, we chose to divide the study population into 2 groups: control group that would be treated the standard accepted preventive treatment: intravenous injection of Mannitol, cooling of the kidney surface, compared to the treatment group that in addition would receive pre- and post-operative treatment of endothelial receptor antagonists (Ambrisentan (Volibris (10mg). To be noticed that the drug is recognized and is given as a primary indication for patients with pulmonary hypertension. The differences between the renal function and biomarkers for pre- and post-operative renal ischemic injury would be examined in order to disclose if the kidney injury of the treated group was indeed smaller. This information will enable us to protect the operated kidneys from the ischemic damage, especially in those patients with poor basic renal function.

Conditions

Kidney Failure, Acute

Outcome Measures

Primary Outcomes (1)

• RENAL FUNCTION INJURY

  quantified by serum CRE, KIM-1,NGAL and urine markers KIM-1 NGAL

  2 YEARS

Study Arms (2)

Treated group

ACTIVE COMPARATOR

Tab. Volibris 10mg given once a day for 5 days, starting 48 hours before surgery (in addition for the standard treatment for partial nephrectomy)

Drug: Ambrisentan 10 MG

Control group

NO INTERVENTION

Treated with the standard treatment for partial nephrectomy

Interventions

Ambrisentan 10 MG DRUG

be given once a day for 5 days, starting 48 hours before surgery

Treated group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a single kidney lesion who undergo Contrast enhancement (by CT scan)
• Normal contra-lateral kidney as illustrated by imaging tests
• Patients eligible for anesthesia and surgery

You may not qualify if:

• Patients with chronic kidney infections
• Blood clot disorders
• End-stage renal failure
• Patients sensitive to the study drug
• Patients with cardiac heart failure, EF \<40%
• Patients with hyperkalemia
• Patients with systolic blood pressure under 90 mmHg

Sponsors & Collaborators

• Bnai Zion Medical Center: lead
• Rambam Health Care Campus: collaborator

Study Sites (2)

Bnai-Zion Medical Center

Haifa, 3339419, Israel

Location

Department of Physiology, The Bruce and Ruth Rapapport Faculty of Medicine, Technion

Haifa, 3525408, Israel

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

ambrisentan

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ofir Avitan, M.D.

  Bnai-zion medical center, Haifa, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Avitan Ofir

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 29, 2020
• Study Start: October 11, 2018
• Primary Completion: February 1, 2020
• Study Completion: October 1, 2020
• Last Updated: June 29, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)