30 Participants Needed

AZD0780 for Kidney Failure

Recruiting at 3 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop some medications. Participants with normal renal function must stop using any prescription or non-prescription drugs 7 days before the study, unless approved by the investigator. Participants with renal impairment must avoid certain medications like potassium binders and phosphate binders 10 hours before and after the study dose, and other specific drugs as outlined in the protocol.

What data supports the idea that AZD0780 for Kidney Failure is an effective treatment?

The available research does not provide any data on AZD0780 for Kidney Failure. The studies mentioned focus on other drugs and conditions, such as prostate cancer and major depressive disorder, but do not include information about AZD0780 or its effectiveness for treating kidney failure.12345

What safety data exists for AZD0780 in treating kidney failure?

The provided research does not contain specific safety data for AZD0780 in treating kidney failure. The articles focus on drug-induced kidney disease, repurposing other drugs for cisplatin-induced AKI, and other nephrology-related topics, but none mention AZD0780 or its safety profile.678910

Is the drug AZD0780 a promising treatment for kidney failure?

The information provided does not mention AZD0780 or its effects on kidney failure, so we cannot determine if it is a promising treatment.1112131415

What is the purpose of this trial?

This is a Phase I, multi-centre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD0780 in male and female participants (females of non-childbearing potential) with severe renal impairment not on dialysis, end-stage renal disease (ESRD) on intermittent haemodialysis (HD), or moderate renal impairment (optional) compared with male and female participants (females of non-childbearing potential) with normal renal function. Potential participants will be screened to assess their eligibility to enter the study up to 4 weeks prior to administration of study intervention. Eligible participants will be admitted to the study site on Day -1. On Day 1, an "A" single oral dose of AZD0780 will be administered, and participants will be confined to the study site until after assessments are completed on Day 11.

Research Team

Kwabena Ayesu, MD

Kwabena Ayesu, MD

Principal Investigator

Omega Research Orlando

Thomas Marbury - President - Orlando ...

Thomas C Marbury

Principal Investigator

Orlando Clinical Research Center

TS

Trisha Shamp, Medicine

Principal Investigator

Nucleus Network

JC

Juan Carlos Rondon, Medicine

Principal Investigator

Clinical Pharmacology of Miami, Inc.

JN

Joel M Neutel

Principal Investigator

Orange County Research Center

Eligibility Criteria

This trial is for adult men and women with severe kidney impairment or end-stage renal disease, who are not on dialysis or are on intermittent hemodialysis. Women must be of non-childbearing potential. Participants should have no other health conditions that could affect the study's results.

Inclusion Criteria

I am healthy with normal kidney function and no significant medical issues.
For Participants with renal impairment: Diagnosis of chronic kidney disease, stable renal function in the 6 months prior to dosing, Received HD for chronic renal failure for at least 3 months prior to dosing (Group 2), Participants with renal impairment, as follows, based on CKD-EPI equation (BSA-adjusted eGFR) at screening: Group1 eGFR < 30 mL/min, not requiring dialysis, Group 2 ESRD (eGFR < 15 mL/min) on a stable intermittent HD schedule for at least 3 months prior to planned dosing and Group 4 (optional) moderate renal impairment (eGFR ≥ 30 to < 60 mL/min), Male participants: Males must be surgically sterile or using, in conjunction with their female partner, a highly effective method of contraception for the duration of the study (from the time of study intervention administration) until 3 months after discharge to prevent pregnancy in a partner, Female participants of non-childbearing potential: Female participants must not be pregnant and must have a negative pregnancy test at screening and check-in, must not be lactating, and must not be of childbearing potential

Exclusion Criteria

For Participants with normal renal function: Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal including bone fractures, endocrine including adrenal insufficiency, metabolic, malignant, psychiatric, major physical impairment), Use of any prescription or non-prescription drugs (including vitamins, recreational drugs, and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before study intervention, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study, History of any major surgical procedure within 30 days prior to study intervention
For Participants with renal impairment: Presence of unstable medical or psychological conditions which, in the opinion of the investigator, would compromise the participant's safety or successful participation in this study, Renal transplant patients (participants on HD with non-functioning renal transplants are not excluded), participants waiting for organ transplant scheduled to occur during the study, and those with a history of acute kidney injury occurring within 3 months prior to screening, History of any major surgical procedure within 30 days prior to study intervention, Current or previous treatment with drugs for reduction or inhibition of PCSK9 (eg, evolocumab, alirocumab, or inclisiran), Use of moderate/strong inhibitors or inducers of CYP3A4/5, Unable to refrain from potassium binders, phosphate binders (eg, aluminium hydroxide and calcium carbonate), cholestyramine/colestipol, and ranitidine/nizatidine within 10 hours before and 10 hours after study intervention, Receiving or has received within 14 days of screening, medication that contains a black box warning for significant QT prolongation. A list of prohibited medications can be found in protocol, Use of concurrent medication which affects calculation of eGFR by affecting serum creatinine (eg, cephalosporin antibiotics, ascorbic acid, trimethoprim, cimetidine, or quinine) within 7 days of Day -1.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive a single oral dose of AZD0780 and are confined to the study site for assessments

11 days
Continuous stay at the study site from Day -1 to Day 11

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • AZD0780
Trial Overview The study tests AZD0780 in individuals with different levels of kidney function, including those with normal function, moderate impairment, severe impairment not on dialysis, and end-stage disease on hemodialysis. It's a single-dose study to see how the drug behaves in the body (pharmacokinetics) and its safety.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Group 4 (optional): AZD0780Experimental Treatment1 Intervention
Participants with moderate renal impairment (eGFR ≥ 30 to \< 60 mL/min).
Group II: Group 3: AZD0780Experimental Treatment1 Intervention
Participants with normal renal function demographically matched by sex, age, and body mass index (BMI) to the impaired participants (eGFR of ≥ 90 mL/min)
Group III: Group 2: AZD0780Experimental Treatment1 Intervention
Participants with ESRD (eGFR \< 15 mL/min) on a stable intermittent HD schedule for at least 3 months prior to planned dosing.
Group IV: Group 1: AZD0780Experimental Treatment1 Intervention
Participants with severe renal impairment (eGFR \< 30 mL/min), not on dialysis.

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Findings from Research

In a study of 51 children with frequently-relapsing/steroid-dependent nephrotic syndrome, rituximab was found to significantly reduce relapse rates and improve quality of life compared to cyclophosphamide and tacrolimus after one year.
Rituximab not only led to fewer relapses and lower cumulative steroid use but also had a better safety profile, with the cyclophosphamide group experiencing twice the frequency of infections compared to the other treatments.
Comparison of rituximab, cyclophosphamide, and tacrolimus as first steroid-sparing agents for complicated relapsing/steroid-dependent nephrotic syndrome in children: an evaluation of the health-related quality of life.Wang, L., Zhu, J., Xia, M., et al.[2022]
In the AFFIRM trial involving 1,199 patients with metastatic castration-resistant prostate cancer, enzalutamide significantly delayed the occurrence of skeletal-related events, with a median time of 16.7 months compared to 13.3 months for placebo (hazard ratio 0.69).
Enzalutamide also improved pain control and health-related quality of life (HRQoL), with 42% of patients reporting overall HRQoL improvement compared to 15% in the placebo group, and a longer median time to HRQoL deterioration (9.0 months vs 3.7 months).
Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial.Fizazi, K., Scher, HI., Miller, K., et al.[2022]
In a phase III trial involving 950 patients with metastatic castrate-refractory prostate cancer, oral satraplatin significantly reduced the risk of disease progression or death by 33% compared to placebo, indicating its efficacy in delaying disease progression.
While satraplatin did not improve overall survival compared to placebo, it effectively delayed pain progression and was generally well tolerated, although some patients experienced more frequent side effects like myelosuppression and gastrointestinal disorders.
Multinational, double-blind, phase III study of prednisone and either satraplatin or placebo in patients with castrate-refractory prostate cancer progressing after prior chemotherapy: the SPARC trial.Sternberg, CN., Petrylak, DP., Sartor, O., et al.[2022]

References

Comparison of rituximab, cyclophosphamide, and tacrolimus as first steroid-sparing agents for complicated relapsing/steroid-dependent nephrotic syndrome in children: an evaluation of the health-related quality of life. [2022]
Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial. [2022]
Multinational, double-blind, phase III study of prednisone and either satraplatin or placebo in patients with castrate-refractory prostate cancer progressing after prior chemotherapy: the SPARC trial. [2022]
Randomized, double-blind comparison of aripiprazole/sertraline combination and placebo/sertraline combination in patients with major depressive disorder. [2019]
The impact of enzalutamide on quality of life in men with metastatic hormone-sensitive prostate cancer based on prior therapy, risk, and symptom subgroups. [2022]
Phenotype standardization for drug-induced kidney disease. [2022]
Repurposing AZD5438 and Dabrafenib for Cisplatin-Induced AKI. [2023]
Nephrology Provider Surprise Question Response and Hospitalizations in Older Adults with Advanced CKD. [2021]
Outcome of End-Stage Renal Disease Patients with Advanced Uremia and Acidemia. [2017]
Comparative risk/benefit profile of biosimilar and originator erythropoiesis-stimulating agents (ESAs): data from an Italian observational study in nephrology. [2018]
[Pharmacokinetics of zidovudine (AZT) and its metabolite (G-AZT) in healthy subjects and in patients with kidney failure]. [2013]
[Pharmacokinetics of aztreonam on hemodialysis]. [2016]
Pharmacokinetics of azithromycin in normal and impaired renal function. [2019]
14.United Statespubmed.ncbi.nlm.nih.gov
Zidovudine disposition during hemodialysis in a patient with acquired immunodeficiency syndrome. [2020]
Pharmacokinetics of zidovudine in HIV-infected patients with end-stage renal disease. [2018]
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