Clinical Trials List
Protocol NumberDMX-200-301
NCT Number(ClinicalTrials.gov Identfier)NCT05183646
Active
2021-12-31 - 2026-12-31
Phase III
Recruiting8
ICD-10N03.1
Chronic nephritic syndrome with focal and segmental glomerular lesions
ICD-10N03.3
Chronic nephritic syndrome with diffuse mesangial proliferative glomerulonephritis
ICD-9582.1
Chronic glomerulonephritis, with lesion of membranous glomerulonephritis
A Pivotal Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of DMX-200 in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving an Angiotensin II Receptor Blocker (ARB)
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 林冠宏 Division of Nephrology
- YUNG-HO HSU Division of Nephrology
- Mei-Yi Wu Division of Nephrology
- 洪冠予 Division of Nephrology
- Chia-Te Liao Division of Nephrology
- I-WEN WU Division of Nephrology
- 高芷華 Division of Nephrology
- Li-Yee Hong Division of Nephrology
- Cai-Mei Zheng Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Te-Chao Fang Division of Nephrology
- 陳靜怡 Division of Nephrology
- Hsi-Hsien Chen Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- VIN-CENT Wu Division of General Internal Medicine
- 黃道民 Division of General Internal Medicine
- 楊紹佑 Division of General Internal Medicine
- 陳怡婷 Division of Family Medicine
- Yung-Ming Chen Division of General Internal Medicine
- - - Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林麗玫 Division of Nephrology
- 張哲銘 Division of Nephrology
- Yi wen chiu Division of Nephrology
- 郭弘典 Division of Nephrology
- 李佳蓉 Division of Nephrology
- 張立昀 Division of Nephrology
- Hung-Chun CHEN Division of Nephrology
- 吳秉勳 Division of Nephrology
- 洪啟智 Division of Nephrology
- 郭美娟 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Junne-Ming Sung
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
FSGS
Objectives
DMX-200 (repagermanium) is a C-C chemokine type 2 receptor (CCR2) inhibitor designed to inhibit the recruitment of mononuclear glomeruli involved in the inflammatory chemokine environment of chronic disease when used concomitantly with an ARB. This hub-and-spoke, double-blind trial aims to investigate the efficacy and safety of DMX-200 120 mg twice daily (BID) versus placebo in adult patients with focal segmental glomerulosclerosis (FSGS) receiving an ARB over a 104-week treatment period. Given the rarity of the disease and the similarity between adult and pediatric FSGS patients, Dimerix will also investigate the efficacy and safety of DMX-200 in adolescents aged 12 to 17 years. Following the double-blind period, an open-label extension (OLE) trial will be conducted to evaluate the long-term efficacy and safety of DMX-200 for up to an additional 2 years.
Test Drug
膠囊劑
Active Ingredient
DMX-200 (Repagermanium)
Dosage Form
130
Dosage
120mg
Endpoints
Primary Objectives
• Percentage change in urine PCR (based on 24-hour urine collection) from baseline to week 35 after DMX-200 treatment compared to placebo.
• eGFR slope from baseline to week 104 after DMX-200 treatment compared to placebo.
Secondary Objectives
• Incidence and severity of adverse events (AEs) after DMX-200 treatment compared to placebo.
• Incidence of clinically significant changes in safety characteristics in patients receiving DMX-200 treatment compared to placebo, measured from baseline by changes in clinical laboratory assessments (hematology, coagulation, clinical chemistry, and urinalysis), ECGs, vital signs, and physical examination.
• Proportion of responders and non-responders after DMX-200 treatment compared to placebo, defined as:
o Complete response: 24-hour urine PCR reduced to <0.3 g/g [<33.9 mg/mmol]
o Modified Partial Clinical Response (FPRE): 24-hour urine PCR decrease of ≥40% from baseline and <1.5 g/g [<169.5 mg/mmol]
o No Response (not meeting any response criteria)
• The proportion of patients receiving DMX-200 who met the comprehensive criteria for worsening renal function compared to placebo, defined as onset of renal failure (start of long-term dialysis, kidney transplantation, or persistent eGFR <15 mL/min/1.73 m2), a 40% decrease in eGFR from baseline, or death from renal or cardiovascular causes.
Open-label extension period:
• Incidence and severity of treatment-related adverse events (AEs) and any AESIs and SAEs following long-term DMX-200 treatment.
• eGFR slope at each follow-up visit based on week 108 (baseline).
• Percentage change in urine PCR at each follow-up visit based on the first morning voiding urine sample.
• Receiving The proportion of patients treated with DMX-200 who meet the comprehensive criteria for deteriorating renal function is defined as the onset of renal failure (start of long-term dialysis, kidney transplantation, or persistent eGFR <15 mL/min/1.73 m2), a 40% decrease in eGFR from baseline, or death due to renal or cardiovascular causes.
• Percentage change in urine PCR (based on 24-hour urine collection) from baseline to week 35 after DMX-200 treatment compared to placebo.
• eGFR slope from baseline to week 104 after DMX-200 treatment compared to placebo.
Secondary Objectives
• Incidence and severity of adverse events (AEs) after DMX-200 treatment compared to placebo.
• Incidence of clinically significant changes in safety characteristics in patients receiving DMX-200 treatment compared to placebo, measured from baseline by changes in clinical laboratory assessments (hematology, coagulation, clinical chemistry, and urinalysis), ECGs, vital signs, and physical examination.
• Proportion of responders and non-responders after DMX-200 treatment compared to placebo, defined as:
o Complete response: 24-hour urine PCR reduced to <0.3 g/g [<33.9 mg/mmol]
o Modified Partial Clinical Response (FPRE): 24-hour urine PCR decrease of ≥40% from baseline and <1.5 g/g [<169.5 mg/mmol]
o No Response (not meeting any response criteria)
• The proportion of patients receiving DMX-200 who met the comprehensive criteria for worsening renal function compared to placebo, defined as onset of renal failure (start of long-term dialysis, kidney transplantation, or persistent eGFR <15 mL/min/1.73 m2), a 40% decrease in eGFR from baseline, or death from renal or cardiovascular causes.
Open-label extension period:
• Incidence and severity of treatment-related adverse events (AEs) and any AESIs and SAEs following long-term DMX-200 treatment.
• eGFR slope at each follow-up visit based on week 108 (baseline).
• Percentage change in urine PCR at each follow-up visit based on the first morning voiding urine sample.
• Receiving The proportion of patients treated with DMX-200 who meet the comprehensive criteria for deteriorating renal function is defined as the onset of renal failure (start of long-term dialysis, kidney transplantation, or persistent eGFR <15 mL/min/1.73 m2), a 40% decrease in eGFR from baseline, or death due to renal or cardiovascular causes.
Inclution Criteria
Inclusion Criteria:
Patients must be 12 to 80 years old
A diagnosis of primary FSGS, genetic FSGS, or FSGS of undetermined cause. Confirmed by kidney biopsy within 7 years of screening
Must be either receiving an ARB at the maximal tolerated dose or willing to transition
If taking corticosteroids, the dosage must be stable for ≥4 weeks prior to Screening and during Stabilization
If taking aldosterone inhibitors, mineralocorticoid receptor antagonists, direct renin inhibitors, sodium-glucose co-transporter-2 (SGLT2) inhibitors, or endothelin receptor antagonists (ERAs, including dual antagonists), the dose and regimen must be stable for ≥12 weeks prior to Screening and during Stabilization
Urine PCR >1.5 g/g (>169.5 mg/mmol) or 24-hour total protein >1.5 g/day based on 24-hour urine collection during Screening.
Estimated eGFR ≥25 and ≤120 mL/min/1.73 m2 at Screening for adults & eGFR ≥25mL/min/1.73 m2 for adolescent patients (<18 years)
Seated blood pressure ≤160/100 mm Hg (mean of 3 values) (patients ≥18 years of age) or between the 5th and 95th percentile for age, sex, and height (patients <18 years of age) at Screening
Body weight ≥35 kg (all patients) AND a body mass index (BMI) ≤40 kg/m2 (patients ≥18 years of age) or between the 5th and 98th percentile for age and sex (patients <18 years of age) at Screening.
A female patient is eligible to participate if she is not pregnant or planning to become pregnant during the study, not breastfeeding, and at least one of the following conditions applies:
Is not of childbearing potential
If of childbearing potential and beginning at menarche, agrees to use a highly effective method of contraception consistently during the treatment period.
A male patient with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception
A patient or parent/legal guardian (as appropriate) who is capable of giving signed informed consent, and where required, the patient is capable of providing assent.
Patients must be 12 to 80 years old
A diagnosis of primary FSGS, genetic FSGS, or FSGS of undetermined cause. Confirmed by kidney biopsy within 7 years of screening
Must be either receiving an ARB at the maximal tolerated dose or willing to transition
If taking corticosteroids, the dosage must be stable for ≥4 weeks prior to Screening and during Stabilization
If taking aldosterone inhibitors, mineralocorticoid receptor antagonists, direct renin inhibitors, sodium-glucose co-transporter-2 (SGLT2) inhibitors, or endothelin receptor antagonists (ERAs, including dual antagonists), the dose and regimen must be stable for ≥12 weeks prior to Screening and during Stabilization
Urine PCR >1.5 g/g (>169.5 mg/mmol) or 24-hour total protein >1.5 g/day based on 24-hour urine collection during Screening.
Estimated eGFR ≥25 and ≤120 mL/min/1.73 m2 at Screening for adults & eGFR ≥25mL/min/1.73 m2 for adolescent patients (<18 years)
Seated blood pressure ≤160/100 mm Hg (mean of 3 values) (patients ≥18 years of age) or between the 5th and 95th percentile for age, sex, and height (patients <18 years of age) at Screening
Body weight ≥35 kg (all patients) AND a body mass index (BMI) ≤40 kg/m2 (patients ≥18 years of age) or between the 5th and 98th percentile for age and sex (patients <18 years of age) at Screening.
A female patient is eligible to participate if she is not pregnant or planning to become pregnant during the study, not breastfeeding, and at least one of the following conditions applies:
Is not of childbearing potential
If of childbearing potential and beginning at menarche, agrees to use a highly effective method of contraception consistently during the treatment period.
A male patient with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception
A patient or parent/legal guardian (as appropriate) who is capable of giving signed informed consent, and where required, the patient is capable of providing assent.
Exclusion Criteria
Exclusion Criteria:
Has FSGS secondary to another condition.
Patients with nephrotic syndrome (>3.5 g/day proteinuria and serum albumin <30 g/L) who have not previously been treated with standard of care FSGS-directed therapies (including steroids).
History of type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (defined as glycated hemoglobin [HbA1c] >8% at Screening)
History of lymphoma, leukemia, or any active malignancy within the past 2 years (except for basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ that have been resected and with no evidence of metastatic disease).
Active clinically significant hepatobiliary disease.
Documented history of heart failure (New York Heart Association Class III/IV) or a major adverse cardiac event within 12 weeks prior to Screening.
Has a physical, medical, or psychological condition, that in the opinion of the Investigator, may interfere with the evaluation the study.
The patient has a history of alcohol or illicit drug use disorder within 1 year prior to Screening.
Had a prior organ transplant or stem cell transplant, with the exception of corneal transplant.
Positive screening assessment for viral hepatitis B surface antigen, or anti-hepatitis C virus (HCV) antibody AND positive HCV RNA, or human immunodeficiency virus 1 and 2.
Serum potassium levels >5.5 mmol/L at Screening.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 × upper limit of normal (ULN) at Screening.
Treatment with non-steroid immunosuppressant agents including biological drugs (e.g. rituximab), calcineurin inhibitors, cyclophosphamide, azathioprine, or mycophenolate mofetil within 12 weeks prior to Screening.
History of serious side effects or allergic response to an angiotensin II antagonist or has a known sensitivity to any components in the IP.
Unable to swallow oral medication.
Prior participation in any Dimerix-sponsored DMX-200 clinical study.
Participation in a clinical study with an investigational product (IP) within 28 days or 5 half-lives (whichever is longer) prior to Screening or plans to participate in another study during the course of this study.
Are study site personnel directly affiliated with this study and their immediate families
Has FSGS secondary to another condition.
Patients with nephrotic syndrome (>3.5 g/day proteinuria and serum albumin <30 g/L) who have not previously been treated with standard of care FSGS-directed therapies (including steroids).
History of type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (defined as glycated hemoglobin [HbA1c] >8% at Screening)
History of lymphoma, leukemia, or any active malignancy within the past 2 years (except for basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ that have been resected and with no evidence of metastatic disease).
Active clinically significant hepatobiliary disease.
Documented history of heart failure (New York Heart Association Class III/IV) or a major adverse cardiac event within 12 weeks prior to Screening.
Has a physical, medical, or psychological condition, that in the opinion of the Investigator, may interfere with the evaluation the study.
The patient has a history of alcohol or illicit drug use disorder within 1 year prior to Screening.
Had a prior organ transplant or stem cell transplant, with the exception of corneal transplant.
Positive screening assessment for viral hepatitis B surface antigen, or anti-hepatitis C virus (HCV) antibody AND positive HCV RNA, or human immunodeficiency virus 1 and 2.
Serum potassium levels >5.5 mmol/L at Screening.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 × upper limit of normal (ULN) at Screening.
Treatment with non-steroid immunosuppressant agents including biological drugs (e.g. rituximab), calcineurin inhibitors, cyclophosphamide, azathioprine, or mycophenolate mofetil within 12 weeks prior to Screening.
History of serious side effects or allergic response to an angiotensin II antagonist or has a known sensitivity to any components in the IP.
Unable to swallow oral medication.
Prior participation in any Dimerix-sponsored DMX-200 clinical study.
Participation in a clinical study with an investigational product (IP) within 28 days or 5 half-lives (whichever is longer) prior to Screening or plans to participate in another study during the course of this study.
Are study site personnel directly affiliated with this study and their immediate families
The Estimated Number of Participants
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Taiwan
32 participants
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Global
286 participants
