NCT05716880 Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome
| NCT ID | NCT05716880 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Military Institute od Medicine National Research Institute |
| Condition | Nephrotic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-01-03 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 150 participants in total. It began in 2023-01-03 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this non-commercial clinical trial is to assess efficacy and safety of ketoanalogues of essential amino acids in the prevention of protein-energy wasting in nephrotic syndrome.
Eligibility Criteria
Inclusion Criteria: * Nephrotic syndrome with serum albumin \< 3.0 g/dL and daily proteinuria of \> 3.5 g/day or \> 50 mg/kg; * New diagnosis or relapse of nephrotic syndrome (defined as: proteinuria of \< 2.0 g/day or uPCR \< 2000 mg/g in the last 6 months prior to relapse and prednison dose equal to or less than 10 mg/day in the last 3 months prior relapse); * Glomerular filtration rate qual to or higher than 30 mL/min/1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. Exclusion Criteria: * Diabetic kidney disease; * Small vessels vasculitis; * Systemic lupus erythematosus; * Positive antinuclear antibodies, anti-dsDNA or antineutrophil cytoplasmic antibodies (ANCA); * Positive anti-HIV or anti-hepatitis C antibodies, HBsAg; * HbA1c \>7%; * Monoclonal gammopathy; * Pregnancy; * Body mass index \>= 40 kg/m2; * Severe acute or chronic disease affecting nutritional status; * Neoplasm; * Contraindication to Ketosteril; * Alcohol or drug abuse; * Mental disorders; * Failure to comply with medical recommendations, lack of cooperation; * Participation in other clinical trial or the use of Ketosteril in the last 1 year prior to screening.
Contact & Investigator
Anna Matyjek
STUDY CHAIR
Military Institute od Medicine National Research Institute
Frequently Asked Questions
Who can join the NCT05716880 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nephrotic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05716880 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 150 participants.
Is NCT05716880 currently recruiting?
Yes, NCT05716880 is actively recruiting participants. Contact the research team at amatyjek@wim.mil.pl for enrollment information.
Where is the NCT05716880 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT05716880 clinical trial?
NCT05716880 is sponsored by Military Institute od Medicine National Research Institute. The principal investigator is Anna Matyjek at Military Institute od Medicine National Research Institute. The trial plans to enroll 150 participants.