Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Substance Related Disorders

Renal Insufficiency

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Vitamins

Vitamin A

Retinol palmitate

Antibodies

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Cystatins

Retinol

blood test for renal biomarkers (uromodulin,Neutrophil gelatinase-associated lipocalin, beta-trace protein, creatinine, cystatin C)

blood test for renal biomarkers

urine test for renal biomarkers (uromodulin, alpha-1 microglobulin, retinol-binding protein, Neutrophil gelatinase-associated lipocalin (NGAL), beta-trace protein, cylinder, albumin, immunoglobulin G (IgG), transferrin, creatinine)

urine test for renal biomarkers

Marc Pfister, Prof MD

This study is to investigate blood and urine kidney injury markers (especially Uromodulin) in pediatric cancer patients treated with nephrotoxic chemotherapy. Uromodulin is a marker to detect and monitor tubular injury and renal function.

Study to Evaluate Blood and Urine Kidney Injury Markers to Facilitate Early Detection of Renal Adverse Drug Events in Pediatric Cancer Patients Treated With Nephrotoxic Chemotherapy

Pilot Study to Evaluate Blood and Urine Kidney Injury Markers to Facilitate Early Detection of Renal Adverse Drug Events in Pediatric Cancer Patients Treated With Nephrotoxic Chemotherapy (Kid-MaCare Oncology)

Change in serum uromodulin levels (ng/ml)

Change in urine uromodulin levels (ng/ml)

Stiftung für Krebskranke Kinder

University Hospital, Basel, Switzerland

Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare 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

Anti-myeloma treatment at physician discretion

Mireya Navarro, MD

A prospective, multicentre, post-authorisation observational study. The objective of this study is assess the response of renal function in clinical practice to anti-multiple myeloma therapy in patients with relapsed MM and CrCl \<50 mL/min/1.73 m2.

Prospective, multicentre, post-authorisation observational study. Study population: Patients with relapsed multiple myeloma and with CrCl \<50 mL/min/1.73 m2, for whom the investigator decides to start a new line of anti-myeloma treatment as per normal clinical practice. The decision to prescribe treatment will be clearly disassociated from the decision to include the patient in the study.

300 patients are expected to be recruited (225 for Group 1 and 75 for Group 2) from 40 sites (approximately 7-8 patients for each site). Patients will be included consecutively in the study.

The inclusion will be stratified to ensure the presence of all stages of renal impairment (RI) in two groups:

Documentation of 300 patients is planned (a maximum of 225 in group 1 and a minimum of 75 in group 2) at 40 sites (approximately 7-8 patients per each site). The patients will be included in the study in a consecutive manner.

In order to ensure the correct stratification of the sample group a real time central registry will be kept for the patients included in each group. Once the required number of patients for one of the groups is completed, inclusion in that group will be closed at all sites, keeping inclusion for other groups open, and so on until the entire sample size is complete.

Primary objective: To assess the response of renal function in clinical practice to anti-multiple myeloma therapy in patients with relapsed MM and creatinine clearance \<50 mL/min/1.73 m2 (CrCl \<50 mL/min/1.73m2).

The prospective follow-up period will cover two phases:

1. Treatment phase: covers the entire time the patient is receiving the first anti-myeloma treatment for relapse\* for which he/she is included in this study.
2. Follow-up phase: A 36-month extension period after the end of the first anti-myeloma treatment for relapse for which he/she was included in the study.

   * Any change in therapeutic regimens, for example, discontinuation or addition of a drug (except for changes in dose for some of the initial drugs) will mark the end of the treatment phase and the passing of the patient to the follow-up phase. In case of temporary interruptions in treatment under 30 days (or of any duration if the reason for interruption is toxicity) the patient will continue in the treatment phase, provided that the initial treatment regimen for the relapse it resumed.

Secondary objectives:

* To describe the clinical and demographic characteristics of patients with relapsed multiple myeloma and CrCl \<50 mL/min/1.73 m2.
* To assess the response rate of renal function in clinical practice to anti-multiple myeloma therapy in patients with relapsed multiple myeloma and CrCl \<50 mL/min/1.73 m2.
* To assess the response of renal function based on the therapeutic regimens administered.
* To explore the concordance of the kidney function response and that of the myeloma in the clinical practice to the anti-myeloma treatment between consecutive relapses in the same patient.
* To assess time-dependent response parameters.
* To analyse the safety of treatments administered in clinical practice.
* To describe the use of resources associated with anti-myeloma therapy in clinical practice that can be measured financially, and to explore the possible differences between the various therapeutic regimens administered.

A Study to Assess Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance

Post-authorisation Observational Study for the Assessment of Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance <50 mL/Min/1.73 m2 (CrCl <50 mL/Min/1.73 m2)

Creatinine records from basal visit to last visit to determinates Creatinine clearance with the Cockcroft-Gault formula.

Patient Age record to determinates Creatinine clearance with the Cockcroft-Gault formula.

Patient weight recorded in each visit to determinates Creatinine clearance with the Cockcroft-Gault formula.

Patient gender recorded in basal visit to determinates Creatinine clearance with the Cockcroft-Gault formula.

To describe the demographic characteristics of patients with relapsed multiple myeloma and CrCl \<50 mL/min/1.73 m2.

To describe the clinical characteristics of patients with relapsed multiple myeloma and CrCl \<50 mL/min/1.73 m2.

Describe response rate of renal function according to eGFR and total proteinuria

Describe various types of anti-myeloma regimens participants will receive.

MM response evaluation according to IMWG criteria

Time to progression is defined as time from baseline to the appearance of the event; considering as an event progression or death from any cause.

Time to response is defined as time from the date of the first dose of study treatment to the date of the first documented hematologic improvement.

Progression free survival is defined as time from the date of the first dose of study treatment to the date of the first documented disease progression or relapse per IWG 2006 criteria.

Number of participants with adverse events

To describe the costs associated with anti-myeloma therapy in clinical practice that can be measured financially, and to explore the possible differences between the various therapeutic regimens administered. This includes, visits to hospital/primary health care center.

Concordance of the kidney function response and that of the myeloma in the clinical practice to the anti-myeloma treatment between consecutive relapses in the same patient.

Celgene

Carcinoma

Carcinoma, Renal Cell

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

The renal artery is occluded to 30% of it's baseline, prior to kidney tumour removal

Hypoperfusion of renal artery

Michael Jewett, M.D.

Many patients who are candidates for nephron-sparing surgery, partial nephrectomy is now the standard treatment with a surgical, small, clinical T1 tumor (\<7 cm). In many recent studies, partial nephrectomy provides equivalent oncologic, and superior functional, outcomes compared with the standard radical nephrectomy over the short and long term (2, 3). Partial nephrectomy techniques, whether open, laparoscopic or robotic, typically involve hilar clamping, which creates the desired bloodless operative field, allowing for more precise tumor excision and renal reconstruction. This hilar clamping eventually may lead to ischemic kidney injury which can compromise the functional outcomes of the remaining kidney.We are working now to develop a novel technique of Hypo-Perfusion by achieving partial renal arterial clamping, with the goal of completely eliminating surgical ischemia to the renal remnant.

Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy

A Pilot Study to Examine a Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy

renal function will be measured using creatinine, eGFR, 24 hr creat clearance, and NGAL biomarker of acute kidney injury

University Health Network, Toronto

Digestive System Diseases

Carcinoma, Hepatocellular

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

Chlorotrianisene

Liver Extracts

Patients undergo TACE of low-osmolar contrast media on day 1.

Patients undergo TACE of iso-osmolar contrast media on day 1.

Gao-Jun Teng, MD

Primary Hepatocellular Carcinoma (PHC) is one of the most common malignant tumors in the world. In men is the fifth most frequently diagnosed cancer worldwide but the second most frequent cause of cancer death. In women, it is the seventh most commonly diagnosed cancer and the sixth leading cause of cancer death. An estimated 748,300 new liver cancer cases and 695,900 cancer deaths occurred worldwide in 2008. Half of these cases and deaths were estimated to occur in China. Surgical resection and liver transplantation can be curative treatment options, but less than 20% of PHC patients are candidates for surgery. The prognosis of patients with unresectable PHC is poor; if left untreated, the median survival is less than 6 months. Since transarterial chemoembolization (TACE) was introduced as a palliative treatment in patients with unresectable HCC, it has become one of the most common forms of interventional therapy. However, the possibility of treatment-related complication may offset the survival benefit, especially by the worsening of liver functions.TACE increases several parameters of hepatic cytolysis and decreases the metabolic activity of the liver. Such a deterioration of liver function due to ischemia following TACE may result in liver failure, or even death. TACE also may have an adverse effect on the kidney. Radiographic contrast medium is used to obtain the hepatogram before TACE. It has been shown that the use of contrast medium increases the risk of renal failure, especially the low-osmolar contrast media. The aim of this trials was to compare the change of liver and renal function after TACE for HCC of iso-osmolar contrast media with that of low-osmolar contrast media.

This was a prospective, randomized, single centre, single-blind study. Patients were randomized (1:1) to use Low-osmolar contrast media or iso-osmolar contrast media for TACE.

On the morning of 2th and 5th days after TACE, a hematologic check was performed, the hematologic check including serum creatinine, blood urea nitrogen, direct bilirubin, indirect bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, lactate dehydrogenase, alkaline phosphatase, cholinesterase. Then, comparing them with the data before TACE.

Comparison of Liver and Renal Function After Transarterial Chemoembolization for Primary Hepatocellular Carcinoma With Iso-osmolar Contrast Media and Low Osmolar Contrast Media

Comparison of Liver and Renal Function After TACE for PHC With Iso-osmolar and Low-osmolar Contrast Media

Li Chen

Zhongda Hospital, Southeast University Nanjing, Jiangsu, China

Nutritional and Metabolic Diseases

Hypertension

Hypersensitivity

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Sunitinib

Rationale: The introduction of angiogenesis inhibitors, like sunitinib and bevacizumab, has improved the outcome of patients with several types of cancer remarkably. However, their application is hampered by side effects, such as development of hypertension with consequences for renal and cardiac function. Moreover patients treated with angiogenesis inhibitors may suffer from weight loss, and insulin sensitivity during treatment appears to change. The treatment with angiogenesis inhibitors, will improve life expectancy of patients with various cancer diagnoses and therefore the clinical relevance of both short term and long lasting adverse events will translate into reduced quality of life. In addition, premature withdrawal of angiogenesis inhibitors due to side effects may result in lower response, shorter duration of response and possibly a shorter survival. Therefore, adequate treatment of above mentioned side effects in patients treated with angiogenesis inhibitors is of relevance for the response rate, the duration of progression free survival and overall survival and for quality of life.

Mechanistic insight in the pathogenesis of these side effects will help optimizing treatment.

Objective: The primary objective of the study is to investigate the effect of sunitinib on endothelial function, insulin sensitivity, renal function and renal blood flow.

Study design: Single-centre non randomized observational study Study population: 30 Patients (\>18 years old) starting with sunitinib as treatment for metastatic renal cell carcinoma.

The Vascular and Metabolic Effects of Sunitinib in Patients With Metastatic Renal Cell Carcinoma

Group A:

Vasomotor response to intra-arterially administered doses of acetylcholine and nitroprusside before and after start sunitinib

Group B:

Insulin sensitivity measured by hyperinsulinemic euglycemic clamp before and after start sunitinib

Group C:

GFR and RPF measured by PAH and inulin clearance before and after start of treatment with sunitinib

Dutch Cancer Society

Radboud University Medical Center

Prof. dr. Rongen

Symptoms and General Pathology

Hypothermia

Body Temperature Changes

After clamping of the renal vessels, no ice slush will be used.

saline ice slush around kidney for 10 minutes.

Within 10 seconds of clamping the renal vessels, the kidney will be encased with saline ice slush for a period of 10 minutes. The slush will be created from sterile saline using an operating room slush machine. The slush is applied by the surgeon and lightly packed around the kidney to ensure complete coverage with at least a 2 cm layer. Slush removal is performed by the surgeon beginning at the 10 minute mark. Enough slush is removed to uncover the tumour area. Surgical incision of the kidney begins as soon as the tumour area is uncovered.

When reconstruction of the kidney is complete, the slush is completely removed from the surgical field and the clamps are removed from the renal vein and artery.

Renal hypothermia

Ilias Cagiannos, MD

The Objective is to determine if renal hypothermia during open partial nephrectomy results in improved post-operative renal function compared to warm ischemia.

Primary Aim is to determine the effect of hypothermia on preservation of overall renal function compared to no hypothermia in patients who require hilar vessel clamping during open partial nephrectomy for a renal tumor.

Hypothesis: Hypothermia will result in improved post-operative preservation of overall renal function.

Secondary Aim is to determine the effect of hypothermia on preservation of affected renal function (kidney with the tumor) compared to no hypothermia in patients who require hilar vessel clamping during open partial nephrectomy for a renal tumor.

Hypothesis: Hypothermia will result in improved post-operative preservation of affected renal function.

The incidence of renal cell carcinoma is increasing and in 2008 it is estimated that over 51,000 new renal cancers will be diagnosed in the United States. To preserve renal function, urologists commonly remove the diseased segment of the kidney (partial nephrectomy) instead of removing the entire kidney (radical nephrectomy). While the benefit of preserving function in patients with renal cell carcinoma has become clear, optimal preservation techniques are yet to be determined. Specifically, the role of hypothermia during partial nephrectomy has been inadequately studied despite theoretical benefit. The investigators objective is to assess the effectiveness of renal hypothermia during partial nephrectomy. The investigators hypothesis is that renal hypothermia during partial nephrectomy results in improved post-operative renal function compared to warm ischemia.

Methods: To test the investigators hypothesis, 180 partial nephrectomy patients will be randomized to cold or warm ischemia. Global and side-specific renal function will be assessed pre-operatively and 12 months post-operatively using radionucleotide clearance and renal scintigraphy.

Significance: To the investigators knowledge, this study will be the first prospective trial to evaluate the clinical impact of renal hypothermia during partial nephrectomy. Since renal function preservation is the primary purpose of partial nephrectomy, these findings will have an important impact on surgical technique and patient outcome.

Renal Hypothermia During Partial Nephrectomy

A Randomized Controlled Trial of Renal Hypothermia During Partial Nephrectomy

Glomerular filtration rate will be measured using the plasma clearance of 99mTc-DTPA.

Side-specific renal function will be calculated by the product of overall glomerular filtration (determined from 99mTc-DTPA plasma clearance) and relative renal contribution (determined from 99mTc-DTPA renal scintigraphy).

Canadian Institutes of Health Research (CIHR)

Ottawa Hospital Research Institute

Ischemia

Central Nervous System Depressants

Anesthetics

Anesthetics, General

patients will have a blood pressure cuff attached to their arm that will not inflate/deflate as in the active group

Patients will have the CellAegis' autoRIC™ Device attached and it will inflate to 200 mmHg in four 5 minute cycles with intervening 5 minutes of reperfusion with the cuff deflated between cycles (while under general anesthetic)

Patients in the active group will have the autoRIC device (like a blood pressure cuff) inflated and deflated to a pressure of 200 mmHg in four 5 minute cycles with intervening 5 minutes of reperfusion with the cuff deflated between cycles

CellAegis' autoRIC™ Device

Partial Nephrectomy has become the standard treatment in patients with tumours \<7cm (T1). Even though this is a nephron sparing surgery, there is still potential for acute kidney injury, due to ischemia during the surgery. Remote Ischemia Preconditioning may prevent acute kidney injury and in turn chronic kidney disease. Remote Ischemia pre-conditioning involves applying a blood pressure cuff and inflating and deflating several times immediately prior to surgery.

Remote Ischemia Pre-Conditioning in Patients Undergoing Partial Nephrectomy

The Effect of Remote Ischemic Preconditioning in Partial Nephrectomy

To measure and compare kidney function (Cr, eGFR) and AKI biomarkers in patients undergoing partial nephrectomy with and without RIPC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Evaluate Blood and Urine Kidney Injury Markers to Facilitate Early Detection of Renal Adverse Drug Events in Pediatric Cancer Patients Treated With Nephrotoxic Chemotherapy	NCT04308642	Kidney Impairme...	blood test for ... urine test for ...	- 18 Years	University Hospital, Basel, Switzerland
A Study to Assess Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance	NCT02849444	Multiple Myelom...	Anti-myeloma tr...	18 Years -	Celgene
Novel Controlled Hypo-Perfusion Technique in Partial Nephrectomy	NCT01720693	Partial Nephrec... Renal Cell Carc...	Hypoperfusion o...	18 Years - 90 Years	University Health Network, Toronto
Comparison of Liver and Renal Function After Transarterial Chemoembolization for Primary Hepatocellular Carcinoma With Iso-osmolar Contrast Media and Low Osmolar Contrast Media	NCT01563484	Primary Hepatoc...		18 Years - 75 Years	Southeast University, China
The Vascular and Metabolic Effects of Sunitinib in Patients With Metastatic Renal Cell Carcinoma	NCT01227213	Hypertension Renal Function Insulin Sensiti... Renal Cell Carc...		18 Years -	Radboud University Medical Center
A Study to Assess Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance	NCT02849444	Multiple Myelom...	Anti-myeloma tr...	18 Years -	Celgene
Renal Hypothermia During Partial Nephrectomy	NCT01529658	Renal Impairmen... Kidney Diseases Urologic Diseas... Cancer Hypothermia Kidney Cancer	Renal hypotherm...	18 Years -	Ottawa Hospital Research Institute
Remote Ischemia Pre-Conditioning in Patients Undergoing Partial Nephrectomy	NCT01771003	Renal Cell Carc...	CellAegis' auto...	18 Years -	University Health Network, Toronto
Comparison of Liver and Renal Function After Transarterial Chemoembolization for Primary Hepatocellular Carcinoma With Iso-osmolar Contrast Media and Low Osmolar Contrast Media	NCT01563484	Primary Hepatoc...		18 Years - 75 Years	Southeast University, China
Renal Hypothermia During Partial Nephrectomy	NCT01529658	Renal Impairmen... Kidney Diseases Urologic Diseas... Cancer Hypothermia Kidney Cancer	Renal hypotherm...	18 Years -	Ottawa Hospital Research Institute
The Vascular and Metabolic Effects of Sunitinib in Patients With Metastatic Renal Cell Carcinoma	NCT01227213	Hypertension Renal Function Insulin Sensiti... Renal Cell Carc...		18 Years -	Radboud University Medical Center

Spots Global Cancer Trial Database for renal function