Clinical trials: Moderate Nephropathy
Acute Kidney Injury
ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)
The purpose of this study is to evaluate the performance of the ProNephro AKI™ (NGAL) test for identifying critically ill adults at risk of developing moderate to severe acute kidney injury (KDIGO Stage 2/3) within 48 to 72 hours…
- Trial name
- ALPACA (NCT07751913)
- Testing
- ProNephro AKI™ (NGAL)
- Where
- 4 sites in United States
- Volunteers
- 800 people
- Sponsor
- BioPorto Diagnostics
Renal Impairment
A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment
The objective of this study is to assess and compare the pharmacokinetic properties of YM178 in normal subjects and those with mild, moderate and severe renal impairment.
- Trial name
- NCT00750620
- Testing
- YM178
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Renal Insufficiency
Afatinib in Subjects With Kidney Dysfunction
The primary objective of the current study is to investigate the influence of moderate to severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in comparison to a control group with normal renal…
- Trial name
- NCT02096718
- Testing
- Afatinib healthy, Afatinib severe renally impaired, Afatinib moderate renally impaired
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Renal Insufficiency, Chronic, Hepatic Insufficiency
Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects
An open-label, single-dose study to evaluate the safety and pharmacokinetics of DIC075V in subjects with mild or moderate chronic renal insufficiency and in patients with mild chronic hepatic impairment compared.
- Conditions
- Renal Insufficiency, Chronic, Hepatic Insufficiency, Healthy
- Trial name
- NCT00805090
- Testing
- Sporanox, Diclofenac Sodium
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Javelin Pharmaceuticals
Chronic Kidney Disease, Renal Insufficiency
Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)
This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI.
- Trial name
- NCT00908310
- Testing
- Omniscan
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- GE Healthcare
Lupus Nephritis, Systemic Lupus Erythematosus
A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis
The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory…
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus, SLE - Systemic Lupus Erythematosus, Lupus Nephritis - WHO Class III
- Trial name
- RECLAIM-LN (NCT07570862)
- Testing
- FT819
- Where
- 12 sites in United States
- Volunteers
- 53 people
- Sponsor
- Fate Therapeutics
Essential Hypertension, Renal Impairment
Olmesartan Medoxomil in Hypertension and Renal Impairment
This is a study in hypertensive patients with mild to moderate renal impairment. The antihypertensive efficacy of olmesartan medoxomil is compared to losartan.
- Trial name
- NCT00151827
- Testing
- Olmesartan medoxomil, Losartan, Furosemide oral tablets
- Where
- Germany
- Volunteers
- 393 people
- Sponsor
- Sankyo Pharma Gmbh
Healthy, Renal Impairment
A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems
This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 20 to 40 kg/m2. People with or without kidney problems can take part in the study.
- Trial name
- NCT06352411
- Testing
- BI 456906
- Where
- 2 sites in Germany
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Graft Rejection, Kidney Failure
Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients
The purpose of the study is to determine the effect of conversion from calcineurin inhibitor based therapy to Rapamune based therapy in patients with mild to moderate renal insufficiency.
- Conditions
- Graft Rejection, Kidney Failure, Kidney Transplantation
- Trial name
- NCT00273871
- Testing
- Cyclosporin or tacrolimus
- Volunteers
- 190 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Renal Impairment
Study of a Single Intravenous (IV) Dose of MK-3402 in Participants With Impaired Renal Function and in Healthy Controls (MK-3402-004)
The purpose of this study is to compare the plasma and urine pharmacokinetics (PK) of MK-3402 in participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3402 is removed…
- Trial name
- NCT04678505
- Testing
- MK-3402
- Where
- 2 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Renal Impairment
Pharmacokinetics Study of TNO155 in Participants With Mild, Moderate, or Severe Renal Impairment Compared to Matched Healthy Participants
The purpose of this Phase 1 study is to evaluate the effect of various degrees of renal impairment on plasma pharmacokinetics (PK), safety and tolerability of TNO155.
- Trial name
- NCT05541159
- Testing
- TNO155
- Volunteers
- healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Renal Impairment
A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)
The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study.
- Trial name
- NCT06295796
- Testing
- MK-8527
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Kidney Diseases, Pruritus
A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral difelikefalin administered as a 1 mg tablet once daily compared to placebo in reducing the intensity of itch in…
- Trial name
- NCT05342623
- Testing
- Difelikefalin 1 mg Oral Tablet
- Where
- 83 sites in United States
- Volunteers
- 286 people
- Sponsor
- Cara Therapeutics, Inc.
Myelofibrosis
PK of Pacritinib in Patients With Mild, Moderate, Severe Renal Impairment and ESRD Compared to Healthy Subjects
This is a Phase 1 open label, single dose, 5 parallel-group study in which a single 400 mg dose of pacritinib will be administered orally to patients with renal impairment (mild, moderate, severe, and patients with ESRD requiring…
- Trial name
- NCT02807077
- Testing
- Pacritinib
- Where
- 3 sites in Germany, Moldova and 1 more
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- CTI BioPharma
Fibrosis, Renal Impairment
Safety of Gadovist in Renally Impaired Patients
Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Gadovist, will be asked to participate.
- Trial name
- GRIP (NCT00828737)
- Testing
- Gadobutrol (Gadovist, BAY86-4875)
- Where
- 70 sites in Australia, Austria and 8 more
- Volunteers
- 927 people
- Sponsor
- Bayer
Heart Failure
BAY94-8862 Dose Finding Trial in Subjects With Chronic Heart Failure and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease
A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally
- Trial name
- ARTS (NCT01345656)
- Testing
- BAY94-8862, Spironolactone
- Where
- 50 sites in Austria, Belgium and 8 more
- Volunteers
- 457 people
- Sponsor
- Bayer
Acute Kidney Injury
Establishment of ProNephro AKI (NGAL) Cut Off Value for Risk Assessment of Moderate to Severe Acute Kidney Injury in Adults
The purpose of this research is to collect blood and urine from adult patients admitted to an intensive care unit. This is to assess the performance of the ProNephro AKI (NGAL) assay (lab test) as an aid to identify patients at…
- Trial name
- EPACRA-AKI (NCT06652100)
- Testing
- ProNephro AKI (NGAL)
- Where
- 12 sites in United States
- Volunteers
- 800 people
- Sponsor
- BioPorto Diagnostics