Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Diseases and Abnormalities at or Before Birth

Neoplasms

Rare Diseases

Acute Kidney Injury

Fibrosis

Cystic Fibrosis

Head and Neck Neoplasms

Pancreatic Diseases

Gastrointestinal Diseases

Lung Diseases

Respiratory Tract Diseases

Genetic Diseases, Inborn

Infant, Newborn, Diseases

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Irene Nunes, OD, PhD

Jessica Ratay, MS

Research Coordinator1

Research Coordinator2

Paul Beringer, PharmD

Joanne Billings, MD

Dave Young, PharmD

The project is designed to test new biomarkers that are more sensitive than the current standard in detecting injury to the proximal kidney tubule and will establish better criteria for when kidney safety concerns may halt further testing of a drug in humans.

The goal of this clinical study is to advance the acceptance of new biomarkers designed to detect drug-induced kidney injury in clinical trials.

The Kidney Safety Project is being conducted at four major medical centers:

* University of Southern California
* University of Minnesota
* MD Anderson Cancer Center
* Dana-Farber Cancer Institute.

Blood and urine samples will be collected from patients undergoing treatment with either cisplatin or aminoglycosides, which are two different drugs known to cause injuries to the proximal tubule of the kidney. Aminoglycosides are a common antibiotic drug taken by patients with cystic fibrosis. Cisplatin is a common chemotherapy drug taken by patients with head and neck cancer.

The Aminoglycoside Study of the Kidney Safety Project is being conducted at the University of Southern California and the University of Minnesota and aims to evaluate aminoglycoside induced acute kidney injury in patients with cystic fibrosis.

The companion study, the Cisplatin Study of the Kidney Safety Project, is being conducted at the MD Anderson Cancer Center and the Dana-Farber Cancer Institute and aims to evaluate cisplatin induced acute kidney injury in patients with head and neck cancer.

The data from the Kidney Safety Project, from both the Aminoglycoside Study and the Cisplatin Study, will be combined for determination of the best biomarkers for predicting drug-induced acute kidney injury.

Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis

University of Southern California

University of Minnesota

M.D. Anderson Cancer Center

Dana-Farber Cancer Institute

Brigham and Women's Hospital

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Amgen

AstraZeneca

Eli Lilly and Company

Johnson & Johnson

Merck Sharp & Dohme LLC

Pfizer

Critical Path Institute

Predictive Safety Testing Consortium

Foundation for the National Institutes of Health

Ischemia

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

Anesthetics

Four cycles of upper arm ischemia/reperfusion

Placement of a blood pressure cuff around upper arm without inflation.

After induction of anesthesia, RIPC consisted of four 5-min cycles of limb ischemia induced by a blood pressure cuff placed on the upper arm and inflated to 250 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated.

Remote Ischemic Preconditioning

After induction of anesthesia, sham control consisted of the placement of a blood pressure cuff on the upper arm with no inflation during the surgery.

Sham control

Won Ho Kim, MD, PhD

This study is intended to evaluate the renal protective effect of Remote Ischemic Preconditioning (RIPC) in patients undergoing partial nephrectomy. Half of the enrolled subjects will receive 4 cycles of brief ischemia on the upper arm after anesthesia induction and prior to the surgery, while the other half will not receive this treatment as a control group.

Remote Ischemic Preconditioning (RIPC) is the concept of mitigating ischemia-reperfusion injury to target organs by a brief episode of ischemia-reperfusion of the limb. The protective effect of RIPC on major organs has been demonstrated in an animal study, but its clinical efficacy has not yet been established.

The kidney is a typical organ vulnerable to ischemic injury, and the renal protective effect of RIPC can be expected. There have been many reports of renal protective effects of RIPC in cardiac and vascular surgery. On the other hand, few studies have investigated the effect of RIPC during partial nephrectomy in which ischemia-reperfusion injury can occur during the surgery.

In this study, the investigators will evaluate the effect of RIPC in patients undergoing partial nephrectomy to prevent renal impairment and improve the prognosis after the surgery.

A prospective, randomized, parallel group, controlled study

Participants, care providers, investigators and outcome assessors will be blinded to group allocation.

The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy

The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy : A Randomized Controlled Trial

Postoperative serum creatinine levels as an index of kidney damage

The incidence of AKI according to the serum creatinine diagnostic criteria of Kidney Disease Improving Global outcomes (KDIGO) Clinical Practice Guideline for AKI

eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).

Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.

Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy

Seoul National University Hospital

Clinical Associate Professor

Renal Insufficiency

Stefan Sultana, MD

Sushrut Waikar, MD

Robert Haddad, MD

Bonnie Glisson, MD

Ala Abudayyeh, MD

Abdulla Salahudeen, MD

The study will be conducted at four major medical centers, including the University of Southern California, the University of Minnesota, the Dana Farber Cancer Institute, and the MD Anderson Cancer Center. Blood and urine samples will be collected from patients undergoing treatment with either cisplatin or aminoglycosides, which are two different drugs known to cause injuries to the proximal tubule of the kidney. Cisplatin is a common chemotherapy drug taken by patients with head and neck cancer. Aminoglycosides are a common antibiotic drug taken by patients with cystic fibrosis.

A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers

Critical Path Institute - Predictive Safety Testing Consortium

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Bortezomib

A reduction in serum FLCs level of more than 80% by day 14 of BCD is defined BCD-AutoHSCT group; A reduction in serum FLCs level of less than 80% by day 14 of BCD is defined BCD-KPD-AutoHSCT group.

Bo Tang, PhD.

Yujun Dong, M.D.

Yangliu Li

Multiple myeloma (MM) is still an incurable hematological tumor, and renal involvement is the main factor of poor prognosis. The recovery of renal function can partially reverse its poor outcome. Although the 5-year survival rate of MM patients has significantly improved after entering the era of new drugs, patients with severe renal insufficiency still have a high early mortality.The purpose of this study is to investigate whether early intensive chemotherapy can reverse the proportion of renal insufficiency, is to investigate the treatment effect of RIMM patients with different renal pathological types, and is also to investigate whether autoHSCT can further partially save renal function in RIMM patients.

For patients with multiple myeloma with renal impairment, the same disease stage and the same treatment regimen have different therapeutic effects. In the era of new drugs, studies have shown that early reduction of the free light chain in serum is the key to reversing renal function. The International Myeloma Working Group recommends the following drugs for the treatment of RIMM patients: 1. regimens based on proteasome inhibitors; 2. regimens based on immunomodulators. Here, we explore a clinical study on the Whole-course Management (BCD-KPD-AutoHSCT) scheme for patients with RIMM.

A Clinical Study on the Whole-course Management (BCD-KPD-AutoHSCT) Scheme for Patients With RIMM

A Clinical Study on the Whole-course Management (BCD-KPD-AutoHSCT) Scheme for Patients With Multiple Myeloma and Kidney Injury

Peking University First Hospital

chief of department of hematology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis	NCT01543620	Cystic Fibrosis		18 Years -	Foundation for the National Institutes of Health
The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy	NCT03273751	Renal Neoplasm Renal Injury	Remote Ischemic... Sham control	20 Years -	Seoul National University Hospital
A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers	NCT01936376	Head and Neck C...		18 Years -	Foundation for the National Institutes of Health
A Clinical Study on the Whole-course Management (BCD-KPD-AutoHSCT) Scheme for Patients With RIMM	NCT06203145	Multiple Myelom... Renal Injury	Bortezomib	18 Years - 70 Years	Peking University First Hospital

Spots Global Cancer Trial Database for renal injury

Every month we try and update this database with for renal injury cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.