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24 active trials for Renal Impairment

Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal Function

Evaluation of the pharmacokinetics (PK) of SPR206 in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD) therapy.

Start: June 2021

Single-Dose Study to Evaluate the PKs of Pretomanid in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

This is a Phase I, open-label, single dose, sequential group study to compare the safety and pharmacokinetics of pretomanid in the following two groups of subjects: 1) those with mild, moderate, and severe renal impairment including those with End Stage Renal Disease (ESRD) not needing dialysis; and 2) matched subjects with normal renal function. The study will be conducted in two parts. Part A will enroll subjects from Groups 1A and 2 (i.e. 6 healthy matched controls and 6 subjects with ESRD, not on dialysis). A decision to enroll subjects into Part B (i.e. to investigate mild, moderate and severe renal impairment) will be conducted after the pharmacokinetics (PK) of the parent compound and safety of subjects enrolled in Part A have been reviewed. Part B will be conducted if the results of Part A demonstrate that patients with ESRD, not on dialysis have different exposures to pretomanid that may impact safety or efficacy relative to the exposures of healthy subjects. If the decision is taken to conduct Part B, 6 subjects each with mild, moderate and severe renal impairment (Groups 3, 4, 5) will be enrolled together with additional healthy matched subjects (Groups 1B-1D). Part B, treatment Groups 3, 4, and 5 will be initiated concurrently when each subject in Groups 1A and 2 has completed Part A of the study. The approximate patient involvement will be 3 months. The primary objective is to evaluate the PK of pretomanid after a single oral dose of 200 mg in subjects with renal impairment compared to matched healthy controls.

Start: August 2019

Surufatinib Renal Impairment Study

An open-label, multicenter, single-dose, single-period, sequential study to assess the effect of moderate renal impairment on the pharmacokinetics of surufatinib.

Start: February 2021

Study to Assess the Pharmacokinetics and Safety of AZD9977 in Participants With Renal Impairment

This is a single dose, non-randomized, open-label, parallel group study. The study will be conducted in participants with severe renal impairment and compared with matched participants with normal renal function. The duration of the study for an individual participant from Screening to Follow-up will be approximately 5 weeks.

Start: June 2020

Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and ESRD

This study is to evaluate the single-dose pharmacokinetics (PK) and safety of Yimitasvir phosphate capsule in participants with End-stage renal disease without hemodialysis using matched healthy participants as a control group.

Start: April 2021

Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal)

The purpose of this study is to determine the pharmacokinetics (PK) and safety for the combination of pomalidomide (POM) + low-dose dexamethasone (LD- DEX) in subjects with relapsed or refractory Multiple Myeloma (RRMM) and impaired renal function.

Start: June 2012

A PK Study of Melphalan During Treatment With Melphalan Flufenamide (Melflufen) and Dex in RRMM Pat With Impaired Renal Function

This is a multicenter, PK study of Melphalan during treatment with Melflufen and Dexamethasone in patients with RRMM and impaired renal function. Received 2 - 4 prior lines of therapy and a renal function (creatinine clearance by Cockcroft-Gault formula) between ?30 mL/min to <45 mL/min in Cohort 1,and ?15 mL/min to <30 mL/min in Cohort 2.

Start: August 2018

A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Renal Impairment

This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild, moderate, severe renal impairment and subjects with kidney failure compared to the matched control subjects with normal renal function.

Start: May 2021

STUDY OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT AND PARTICIPANTS WITHOUT RENAL IMPAIRMENT

This study will characterize the effect of varying degrees of renal impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of PF- 06882961 compared with participants with normal renal function.

Start: January 2021

A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Renal Function

The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of fezolinetant and ES259564 (fezolinetant metabolite) in female participants with varying levels of renal impairment (mild, moderate and severe) compared to healthy female participants with normal renal function. This study will also evaluate the safety and tolerability of a single oral dose of fezolinetant in female participants with varying levels of renal impairment (mild, moderate and severe) and healthy female participants with normal renal function. Renal function will be measured by estimated glomerular filtration rate (eGFR) using the modification of diet in renal disease (MDRD) formula: Mild (eGFR 60 to < 90 mL/min per 1.73 m^2) renal impairment; moderate (eGFR 30 to < 60 mL/min per 1.73 m^2) renal impairment, severe (eGFR < 30 mL/min per 1.73 m^2) renal impairment and not on hemodialysis and normal (eGFR ? 90 mL/min per 1.73 m^2) renal function.

Start: August 2020

Neuromuscular Blockade in Patients With Severe Renal Impairment

This study is intended to be a single-site, prospective, randomized, double-blinded study that intends to enroll a total of 60 patients with severe renal impairment undergoing surgery with general endotracheal anesthesia at Parkland Hospital. Patients will be randomized to receive either neostigmine (for reversal of cisatracurium) or sugammadex (for reversal of rocuronium). A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care. All patients will be monitored with continuous pulse oximetry postoperatively for 24 hours.

Start: December 2019

A Study to Evaluate the Effect of Renal Impairment on JNJ-42847922 in Adult Participants

The purpose of this study is to evaluate the pharmacokinetic of a single oral dose of JNJ-42847922 in adult participants with renal impairment compared with healthy participants with normal renal function.

Start: February 2021

Study to Assess Adverse Events and the Movement of Oral Venetoclax Tablet Through the Body of Female Participants Aged 18-75 Years With Impaired Renal Function

Renal insufficiency is common in participants with blood cancers. The main objective of this study is to evaluate adverse events and movement of oral venetoclax tablets through the body of female participants with severe normal renal function and those with end stage renal disease (ESRD) requiring hemodialysis. Venetoclax is an investigational drug being developed for the treatment of various hematologic malignancies. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. Approximately 12 female participants between 18 and 75 years, with Body Mass Index (BMI) between 18 to 42 kg/m2 will be enrolled in approximately 4 sites across the world. Participants with normal renal function will receive single dose of oral venetoclax tablet. Participants with ESRD will receive oral venetoclax tablets just prior to hemodialysis (Period 1 Day 1) and between dialysis days (Period 2 Day 1), doses in the two periods will be separated by at least 7 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and urine tests, checking for side effects.

Start: March 2021

Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal Impairment

This is a 2-segment, multi-center, phase 1, open-label, study evaluating the pharmacokinetics and pharmacodynamics of AR882 in subjects with various degrees of renal impairment.

Start: January 2021

Renal Impairment Study of PF-06700841

The purpose of this study is to characterize the effect of kidney impairment on the blood concentrations of PF-06700841 and its major metabolite. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of kidney disease.

Start: July 2020

Renal Biopsy Unexplained Elevated Serum Creatinine

Patients presented with unexplained elevated serum creatinine including vast varieties of acute or chronic kidney disease. Renal biopsy may include acute and chronic interstitial nephritis, glomerulosclerosis and tubular atrophy, acute tubular necrosis, rapidly progressive glomerulonephritis, granulomatous glomerulonephritis, monoclonal gammopathy, myeloma kidney or thrombotic microangiopathy . Renal biopsy definitely still plays the most vital and irreplaceable role in the investigations of cases with unexplained renal impairment. Despite a vastly variable biopsy results between patients, renal biopsy has helped in determining the best treatment and prognosis for the patients.

Start: August 2018

A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys

It is hoped that mobocertinib will eventually help people with cancer with severely reduced kidney function. The main aim of this study is to learn about the levels of mobocertinib in the blood and urine of participants with severely reduced kidney function and participants with healthy kidneys. These participants do not have cancer. The information from this study will be used to work out the best dose of mobocertinib for people with cancer with severely reduced kidney function in the future. At the first visit, the study doctor will check who can take part. Participants who can take part will be placed into 1 of 2 treatment groups. Participants with severely reduced kidney function will be in 1 group. Participants with healthy kidneys will be in the other group. Participants in both groups will receive the same treatment and the group results will be compared. Participants from both groups will take 1 capsule of mobocertinib. They will stay in the clinic for 10 days so the study doctors can check the amount of mobocertinib in the blood and urine of these participants over time. The study doctors will also check if the participants have any side effects from this treatment. The clinic will call the participants 30 days after they took mobocertinib to check if they have any more side effects from their treatment.

Start: March 2020

A Pharmacokinetic Study of Saroglitazar Magnesium in Subjects With Severe Renal Impairment and Normal Renal Function

This will be a Phase 1, Open-label Study of Participants with Normal Renal Function and Participants with Sever Renal Impairment.

Start: July 2020

PK Study in Subjects With Renal Impairment (Severe and if Required Mild & Moderate) Compared to Subjects With Normal Renal Function

This is an open-label, non randomised, single-dose, study in male and female subjects with renal impairment (severe and if required mild & moderate) compared to male and female subjects with normal renal function.

Start: December 2020

Study of ALXN2050 in Participants With Renal Impairment

This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with impaired renal function.

Start: January 2021