CompletadoNCT04123613Registro de ClinicalTrials.gov

Multiple Doses of DM199 in Patients With Chronic Kidney Disease (REDUX)

Kidney Diseases

Pregúntale a WCR sobre este estudio Registro oficial ↗

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: Fase 2
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 84 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

An open-label, Phase II, multi-center study evaluating multiple doses of DM199 in participants with chronic kidney disease.

Leer la descripción completa

This is an open-label, Phase II, multi-center study evaluating DM199 in approximately 90 Participants in three cohorts.

Cohort I: African Americans with CKD (Stage II or III), hypertension and non-diabetic Cohort II: Participants with IgA nephropathy diagnosis and CKD (Stage II or III) Cohort III: Diabetes Mellitus (Type II) with CKD (Stage II or III) and hypertension

Participants in each cohort will be enrolled in a parallel assignment to one of two doses:

Dose 1: DM199 2.0 µg/kg SC 2x week for 95 days Dose 2: DM199 5.0 µg/kg SC 2x week for 95 days

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

Cohort I

African American
Hypertension as defined by the American Heart Association for Stage I hypertension where systolic blood pressure (BP) ≥130 mmHg or diastolic BP ≥ 80 mmHg or on medication for treatment of hypertension.

Cohort II

IgA nephropathy confirmed by medical history with biopsy

Cohort III

Diabetes Mellitus (Type 2) with hypertension where systolic blood pressure (BP) ≥130 mmHg or diastolic BP ≥ 80 mmHg or on medication for treatment of hypertension
Hemoglobin A1c ≥7% at screening

Both Cohorts

Participant is willing and able to provide informed consent for study participation
Participant male or female ≥ 18 years of age
Participant has CKD as defined by using CKD EPI for Stage II 60 to \<90 mL/min/1.73 m2 or Stage III 30 to \<60 mL/min/1.73 m2
UACR \>150 mg/g and \<5000 mg/g at screening
Participant is clinically stable with respect to underlying renal impairment as assessed by the Investigator's medical evaluation

Exclusion Criteria:

Participant has positive drug test for drugs of abuse and/or positive alcohol breath test at screening and Day 1
Participant has a current diagnosis and/or is taking medication or diet control for diabetes (cohort I and II only)
Participant has an A1c \> 7% at screening (cohort I and II only)
Participant received corticosteroid therapy within last 3 months
Participant is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits
Participant has a history of significant allergic diathesis such as urticaria, angioedema, or anaphylaxis
Participant has been previously diagnosed with kidney disease other than for hypertension, IgA or Diabetes Mellitus (Type II)
Participant has hypotension as defined by systolic blood pressure ≤ 90 mmHg and diastolic blood pressure ≤ 60 mmHg at screen
ACEi or GLP-1 medication prescribed for and taken by Participant (must not be taking for 5 half-lives prior to study drug administration and for 10 days post study drug administration)
Participant has a current malignancy or active malignancy ≤ 2 years prior to enrollment except basal cell or squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy and ≥ 6 months have elapsed since the procedure
Participant has an active infection at the time of enrollment, and/or a history of clinically significant acute bacterial, viral, or fungal systemic infections that required systemic treatment with a completed therapy in the last 7 days prior to enrollment
Participant has known medical history of alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency)
Participant is pregnant or nursing or is planning a pregnancy during the study period
Participant is male or female of childbearing potential, is participating in sexual activity that could lead to pregnancy and is unable or unwilling to practice medically effective contraception during the study
Participant has received any investigational drug or device within 14 days (or 5 half lives, whichever is longer) prior to study drug administration starting on Day 1
Participant has renal artery stenosis as determined at screen with medical history
Participant received a kidney transplant
Participant does not have adequate venous access for blood sampling
Participant has any other medical condition which, in the opinion of the Investigator, will make participation medically unsafe or interfere with the study results
Participant has any other clinically significant abnormalities in laboratory test results at screening that would, in the opinion of the Investigator, increase the Participant's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data
Participant has any significant arrhythmia or conduction abnormality, which in the opinion of the Investigators and Medical Monitor may interfere with the safety of the Participant

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Sin asignación al azar
Enmascaramiento: Sin enmascaramiento

2.0 µg/kg, multiple dose

n=45 with 15 Participants from cohort 1, 15 from cohort 2, and 15 from cohort 3

Drug: DM199

5.0 µg/kg, multiple dose

n=45 with 15 Participants from cohort 1, 15 from cohort 2 and 15 from cohort 3

Drug: DM199

DM199 DRUG

A pharmaceutical formulation comprised of recombinant human tissue kallikrein-1 (rhKLK-1) that is being developed as an injectable protein drug

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Safety as Assessed by Incidence, Severity and Causality of AEs

Plazo: From initial dose (Day 1) through Day 104

The safety population includes all participants who received at least one dose of the study intervention and were evaluated for safety outcomes. Data are summarized using this population to provide a comprehensive assessment of treatment-related adverse events, tolerability, and overall safety, ensuring consistent interpretation of safety findings across study groups.

Estimated Glomerular Filtration Rate (eGFR), Change From Baseline

Plazo: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16

Estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, and eGFR measurements were obtained at baseline and every two weeks through week 16. This longitudinal assessment allowed for the evaluation of trends, stability, or potential treatment-related effects on kidney function, providing important clinical context for interpreting the study outcomes and the overall renal safety profile of the study population.

Urine Albumin to Creatinine Ratio (UACR), Change From Baseline

Plazo: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, and 16

Urine albumin-to-creatinine ratio (UACR) was assessed as a measure of urinary albumin excretion and kidney health throughout the 16-week period. UACR was calculated from spot urine samples by dividing the urine albumin concentration by the urine creatinine concentration, providing a standardized assessment that minimizes the impact of urine dilution. Measurements were obtained at predefined study visits to evaluate changes from baseline and to monitor the effects of treatment on albuminuria over time. UACR is a clinically relevant marker of kidney damage and disease progression, with higher values generally indicating greater renal impairment and increased risk of adverse kidney and cardiovascular outcomes. Longitudinal assessment of UACR provided important information regarding treatment response, renal function preservation, and the overall kidney-related effects of the study intervention. Note: UACR values are reported in g/kg, which is equivalent to mg/g.

Systolic Blood Pressure, Change From Baseline

Plazo: Baseline, Day 4 through Day 95

Blood pressure was taken at the timepoints defined in the Schedule of Assessments after the participant had been sitting for at least 5 minutes.

Diastolic Blood Pressure, Change From Baseline

Plazo: Baseline, Day 4 through Day 95

Blood pressure was taken at the timepoints defined in the Schedule of Assessments after the participant had been sitting for at least 5 minutes.

Urine KLK1 Concentration Pre and Post DM199 Administration

Plazo: Baseline through Day 104

Observed urine concentration of KLK1 throughout the treatment period.

Plasma KLK1 Concentration Pre and Post DM199 Administration

Plazo: Baseline through Day 104

Observed KLK1 concentration throughout the treatment period.