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Nephrotic SyndromePhase 3FORMANCT05716880

Ketoanalogues for Muscle Mass Loss in Nephrotic Syndrome

A Phase 3 study testing Ketosteril and Medium Protein Diet (MPD) in people with Nephrotic Syndrome, run by Military Institute od Medicine National Research Institute at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nephrotic Syndrome
What is being tested?
Ketosteril and Medium Protein Diet (MPD)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 sitePoland
Study dates
3 Jan 2023to 31 Aug 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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%;
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anna Matyjek, MD, PhD contact

261817045 ext. +48

amatyjek@wim.mil.pl

Poland1 site, 1 recruiting

  • Department of Internal Diseases, Nephrology and Dialysis, Military Institute of Medicine - National Research Institute

    Warsaw, Masovian District, 04-141

    Anna Matyjek, MD, PhD, 261817045 ext. +48, amatyjek@wim.mil.pl

    Stanislaw Niemczyk, MD, PhD, Prof.

    Recruiting

Other trials in Poland

About this study

Official title: FORMA - a Multicenter Randomized-controlled Trial to Evaluate the Efficacy and Safety of Ketoanalogues of Essential Amino Acids in Prophylaxis of Protein-energy Wasting in Nephrotic Syndrome

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.

Read the detailed description

Adult patients with new diagnosis or relapse of nephrotic syndrome and glomerular filtration rate of ≥ 30 mL/min/1.73m2 will be included in the study. Exclusion criteria will be a secondary cause of nephrotic syndrome, morbid obesity and severe diseases affecting nutritional status.

Participants will be randomly assigned to the intervention group (KA+MPD) or control group (MPD); randomization will be stratified by type of glomerular disease (podocytopathy or other type) and investigational site. The control group will follow the diet recommended in nephrotic syndrome - a medium protein diet (MPD) - under the care of a dietitian. Intervention group will receive Ketosteril (1 tablet for every 5 kg of ideal body weight) as an addition to the diet. All patients will also receive treatment for underlying glomerular disease in accordance with current guidelines and local practice.

The main objective is to assess the efficacy of Ketosteril as an add-on therapy in preventing the loss of lean tissue mass (LTM) over 6 months compared to a standard diet.

The additional aims include the assessment of muscle function parameters, nephrotic syndrome severity and laboratory indicators of catabolism.

Being tested
Ketosteril, Medium Protein Diet (MPD)
Keywords
nephrotic syndrome, protein-energy wasting, neph-PEW, lean tissue mass, Ketosteril, ketoanalogues
Medical subject headings
Nephrotic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetosterilDrug

    Daily dose = 1 tabl / 5 kg of ideal body weight

  • Medium Protein Diet (MPD)Other

    MPD: daily protein intake of 0.8-1.0 g/kg of ideal body weight + up to 5 g based on daily proteinuria

Study groups in NCT05716880
Study groupRoleWhat they receive
KA+MPDExperimentalKetosteril + Medium Protein Diet (MPD) for 12 months
Receives: Drug: Ketosteril; Other: Medium Protein Diet (MPD)
MPDActive comparatorMedium Protein Diet (MPD) for 12 months
Receives: Other: Medium Protein Diet (MPD)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum loss of lean tissue mass

    The difference between the initial lean tissue mass (LTM) and the lowest LTM measured within 6 months, expressed in percentage. The non-inferiority hypothesis of Ketosteril use will be tested as the primary endpoint.

    LTM will be measured with bioimpedance spectroscopy.

    Measured: 6 months

Secondary outcomes (11)

  1. Maximum loss of lean tissue mass

    The difference between the initial lean tissue mass (LTM) and the lowest LTM measured within 6 months, expressed in percentage. The superiority hypothesis of Ketosteril use will be tested as the secondary endpoint.

    Measured: 6 months

  2. Neph-PEW diagnosis

    The percentage of patients meeting criteria of nephrotic syndrome-associated protein-energy wasting (neph-PEW): reduction of LTM by 3% within 3 months or by 5% within 6 months.

    Measured: 6 months

  3. 6-minute walk test distance

    Change in distance walked in the 6-minute walk test from baseline value; expressed in meters.

    Measured: 6 months

  4. Handgrip strength (HGS)

    Change in HGS value from baseline; expressed in kg.

    Measured: 6 months

  5. Serum albumin

    Change in serum albumin level from baseline value; expressed in g/dL.

    Measured: 6 months

  6. Urinary protein/creatinine ratio (uPCR)

    Change in uPCR value from baseline; expressed in mg/g.

    Measured: 6 months

  7. Low density lipoprotein (LDL)

    Change in serum LDL level from baseline; expressed in mg/dL.

    Measured: 6 months

  8. Triglycerides

    Change in serum triglycerides level from baseline; expressed in mg/dL.

    Measured: 6 months

  9. Uric acid

    Change in serum uric acid level from baseline; expressed in mg/dL.

    Measured: 6 months

  10. Unfavorable disease course

    The percentage of patients who experienced the unfavorable disease course including: glomerular disease related death; venous or arterial thromboembolic event; infection requiring hospital admission; acute kidney injury in the stage 2 or 3; sustained glomerular filtration rate reduction over 50% or initiation of kidney replacement therapy; unplanned hospital admission due to complications of nephrotic syndrome treatment.

    Measured: 12 months

  11. Glomerular filtration rate

    Change in glomerular filtration rate from baseline; expressed in mL/min/1.73m2.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study start3 Jan 2023
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomization in 1:1 ratio with stratification by the type of glomerular disease (podocytopathy versus other type) and investigational site
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05716880
Sponsor's protocol ID
ABM/FORMA/2021
Other IDs
2022-000529-26, 2021/ABM/01/00036-00
Acronym
FORMA
Status last verified
Jan 2023
First submitted
30 Jan 2023
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Matyjek A, Literacki S, Niemczyk S, Rymarz A. Protein energy-wasting associated with nephrotic syndrome - the comparison of metabolic pattern in severe nephrosis to different stages of chronic kidney disease. BMC Nephrol. 2020 Aug 14;21(1):346. doi: 10.1186/s12882-020-02003-4.

    PubMed 32795277

  • Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021 Oct;100(4S):S1-S276. doi: 10.1016/j.kint.2021.05.021. No abstract available.

    PubMed 34556256

  • Fouque D, Kalantar-Zadeh K, Kopple J, Cano N, Chauveau P, Cuppari L, Franch H, Guarnieri G, Ikizler TA, Kaysen G, Lindholm B, Massy Z, Mitch W, Pineda E, Stenvinkel P, Trevino-Becerra A, Wanner C. A proposed nomenclature and diagnostic criteria for protein-energy wasting in acute and chronic kidney disease. Kidney Int. 2008 Feb;73(4):391-8. doi: 10.1038/sj.ki.5002585. Epub 2007 Dec 19.

    PubMed 18094682

  • Kaysen GA, Gambertoglio J, Jimenez I, Jones H, Hutchison FN. Effect of dietary protein intake on albumin homeostasis in nephrotic patients. Kidney Int. 1986 Feb;29(2):572-7. doi: 10.1038/ki.1986.36.

    PubMed 3702214

  • Barsotti G, Morelli E, Cupisti A, Bertoncini P, Giovannetti S. A special, supplemented 'vegan' diet for nephrotic patients. Am J Nephrol. 1991;11(5):380-5. doi: 10.1159/000168342.

    PubMed 1809035

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ketosteril and Medium Protein Diet (MPD) in people with Nephrotic Syndrome, run by Military Institute od Medicine National Research Institute at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna Matyjek, MD, PhD (261817045 ext. +48, amatyjek@wim.mil.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum loss of lean tissue mass (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05716880, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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