Skip to main content
MedPathMedPath Home
Clinical Trials/NL-OMON52170
NL-OMON52170
Completed
Phase 2

A Phase 2b Multicentre, Randomised, Double-Blind, Active Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of Zibotentan and Dapagliflozin in Patients with Chronic Kidney Disease with Estimated Glomerular Filtration Rate (eGFR) Between 20 and 60 mL/min/1.73 m2 - Zenith-CKD

Astra Zeneca0 sites9 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Astra Zeneca
Enrollment
9
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Trial is onging in other countries

Registry
who.int
Start Date
TBD
End Date
May 23, 2023
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Astra Zeneca

Eligibility Criteria

Inclusion Criteria

  • •Participants are eligible to be included in the study only if all of the
  • •following criteria apply:
  • •1 Participant must be 18 years of age or older at the time of signing the
  • •informed consent.
  • •Type of Participant and Disease Characteristics / Laboratory Parameters
  • •2 Diagnosis of CKD, defined as:
  • •(a) eGFR (CKD\-EPI) \>\= 20 mL/min/1\.73 m2 (by CKD\-EPI formula, see Section 8\.1\.2\.2\)
  • •(b) Urine albumin to creatinine ratio (UACR) \>\= 150 and \<\= 5000 mg albumin/g
  • •creatinine,
  • •based on a single first morning void spot urine sample at screening.

Exclusion Criteria

  • •Participants are excluded from the study if any of the following criteria apply:
  • •Medical Conditions
  • •1 Minimal change disease, unstable rapidly progressing renal disease, and/or
  • •renal disease
  • •requiring significant immunosuppression, autosomal dominant or autosomal
  • •recessive polycystic kidney disease.
  • •2 Participants with NYHA functional HF class III or IV.
  • •3 Acute coronary syndrome (ACS) events within 3 months prior to screening.
  • •4 Participants with a BNP \>\= 200 pg/mL or NT\-proBNP \>\= 600 pg/mL (BNP \>\= 400 pg/mL
  • •or NT\-proBNP \>\= 1200 pg/mL, respectively, if associated with atrial

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Phase 2
A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitisinflamatory bowel diseaseUlcerative colitis10017969
NL-OMON46940Eli Lilly and Company7
Completed
Phase 2
A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability Of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosism (ALS)Motor Neuron Disease10029317
NL-OMON45879Cytokinetics, Inc.11
Completed
Phase 2
A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia
NL-OMON45499Madrigal Pharmaceuticals, Inc.24
Completed
Phase 2
A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study with Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys with Duchenne Muscular Dystrophy (DMD)
NL-OMON50318ReveraGen BioPharma, Inc.7
Recruiting
Phase 2
A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd® Therapy Administered into Lymph Nodes Combined with Oral Vitamin D to Investigate the Impact on the Progression of Type 1 diabetesType 1 diabetesDiabetes10018424
NL-OMON49006Diamyd Medical AB2