A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in DKD Patients
ConditionDiabetic Kidney Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age30+
SponsorAlebund Pharmaceuticals
About this trial
The study will be a single center, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to Diabetic Kidney Disease patients.
Eligibility criteria
Qualifiers
Male and female participants, ≥30 years of age at the time of signing the informed consent form.
BMI (body mass index) 18-30 kg/m².
Patient has a clinical diagnosis of Type 2 Diabetes Mellitus and is taking at least one type of hypoglycemic drugs, before screening visits, the doses of hypoglycemic drugs, including insulin, need to be stable for at least two weeks..
Patient must be on a stable dose of angiotensin converting anzyme inhibitior (ACEI) or Angiotensin II receptor blockers (ARB) for at least 4 weeks prior to screening.
Disqualifiers
Chronic kidney disease other than type 2 diabetic kidney disease.
Patient receiving corticosteroid immunotherapy or other immunosuppressants (such as calcineurin inhibitors ciclosporin, cyclophosphamide, or mycophenolate mofetil) in the past 3 months before screening.
Recently having acute kidney injury or received renal surgery within the last 6 months before screening visit, or have received renal transplantation.
Congestive heart failure classified New York Heart Association (NYHA) class II to IV within the last 3 months before the screening visit.
Trial design
Treatments tested in this trial
- AP303 150μg
- Placebo 150μg
Treatment groups
18 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov