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Anakinra for the Treatment of Postprandial Hypoglycemia in a Patient With Total Gastrectomy and End-Stage Renal Disease (AnPHy-ReD)

2026. május 5. frissítette: Marc Donath

Anakinra for the Treatment of Recurrent Postprandial Hypoglycemia After Total Gastrectomy in a Patient With End-Stage Renal Disease

Post-meal low blood sugar (postprandial hypoglycemia) is a common problem after certain stomach surgeries like gastric bypass or stomach removal. It usually happens 1 to 3 hours after eating and can cause symptoms such as tiredness, hunger, sweating, dizziness, trouble speaking, or even fainting. Right now, there is no approved medication for this condition-only a careful diet reduced in sugars and refined carbohydrates can sometimes help reduce symptoms.

The AnPHy-ReD study is a personalized research study, designed for just one patient. This patient is a 52-year-old man who has been struggling with severe post-meal low blood sugar ever since his stomach was removed due to tumor in 2017. He also has end-stage kidney disease and needs dialysis three times a week.

The study is being conducted at the Cantonal Hospital of Olten in Switzerland and lasts 10 weeks, including 24 study visits. Most of these visits will happen during the patient's regular dialysis sessions. For 6 weeks, the patient will take either the drug Anakinra or a placebo (a substance with no active ingredient), in a randomly chosen order. Neither the patient nor the doctors will know which one he is taking at any given time.

During the study, the medical team will perform various tests, including physical check-ups and blood samples to look at sugar levels, various hormone levels and inflammation in the body. The patient will also wear a continuous glucose monitor (CGM) to track his blood sugar levels 24/7. In addition, he will do several mixed meal tests-this means drinking a shake containing fats, proteins, and sugars during a study appointment to see in real time how his body processes food, with doctors measuring changes in blood sugar, hormone and inflammation markers over time. During the study duration any side effects or symptoms will be closely monitored.

At the end of the study, the team will compare the results between the times the patient took Anakinra and the times he took the placebo. This will help find out if Anakinra can reduce sharp drops in blood sugar after meals and improve his overall condition.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

1

Fázis

  • 2. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Svájc
    • Canton of Solothurn
      • Olten, Canton of Solothurn, Svájc, 4600
        • Kantonsspital Olten
        • Kapcsolatba lépni:
        • Kutatásvezető:
          • Matthias Hepprich, PD Dr. med.

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Gyermek
  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

This is an N-of-1 Trial, tailored-designed to a single participant.

  • total gastrectomy
  • severe episodes of postprandial hypoglycaemia after total gastrectomy

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Crossover kiosztás
  • Maszkolás: Kettős

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Placebo Comparator: Placebo Treatment Periods

The interventional period consists of four treatment blocks, each containing four visits. During each visit, the patient receives either Anakinra (A) or placebo (P) in a double-blinded manner, according to a randomized schedule. The sequence within each block (e.g., A-A-P-P or P-A-A-P) is randomly assigned in advance by an independent scientist, ensuring a balanced and unbiased comparison of treatments throughout the trial.

Study visits take place during the patient's regular dialysis sessions. On each visit, the assigned treatment is administered via the hemodialysis blood circuit over 1 minute during the last 30 minutes of each dialysis session by the dialysis personnel.
Drog: Placebo Comparator (0.9% NaCl)

Placebo comparator will be 0.9% saline solution. A similar size and type of syringe will be used as for the Anakinra syringe making it difficult to distinguish which treatment of the two the patient is receiving.

The patient will receive 0.9% saline solution intravenously through the haemodialysis circuit 30 minutes before the end of the dialysis session, following the same administration procedure as Anakinra to maintain blinding.
Kísérleti: Anakinra Treatment Periods
The interventional period consists of four treatment blocks, each containing four visits. During each visit, the patient receives either Anakinra (A) or placebo (P) in a double-blinded manner, according to a randomized schedule. The sequence within each block (e.g., A-A-P-P or P-A-A-P) is randomly assigned in advance by an independent scientist, ensuring a balanced and unbiased comparison of treatments throughout the trial. Study visits take place during the patient's regular dialysis sessions. On each visit, the assigned treatment is administered via the hemodialysis blood circuit over 1 minute during the last 30 minutes of each dialysis session by the dialysis personnel.
Drog: Anakinra (interleukin-1 receptor antagonist)

Anakinra (Kineret®; r-metHuIL-1ra, Swedish Orphan Biovitrum AB) is a recombinant, non-glycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra). It is a clear, colourless-to-white solution, provided as a 150mg/mL solution in pre-filled syringes, each containing of 100 mg of Anakinra in 0.67ml.

On the assigned study days, the patient will receive in a double-blind manner 100 mg of Anakinra intravenously through the hemodialysis circuit, administered 30 minutes before the end of the dialysis session.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Mean Amplitude of Sensor Glucose Excursions (MAGE) during Anakinra treatment compared to placebo
Időkeret: Through the 40-day interventional period
Mean Amplitude of Sensor Glucose Excursions (MAGE) during Anakinra treatment compared to placebo, assessed using cumulative data from Continuous Glucose Monitoring System from all 48-hour treatment periods (48 hours following study-drug administration, Anakinra or Placebo).
Through the 40-day interventional period
Prevalence and severity of postprandial hypoglycaemia symptoms during Anakinra treatment compared to placebo
Időkeret: Through the 40-day interventional period

Prevalence and severity of postprandial hypoglycaemia symptoms during Anakinra treatment compared to placebo, assessed using cumulative data from Continuous Glucose Monitoring from all 48-hour treatment periods.

Post-prandial hypoglycaemia symptoms and their severity will be evaluated by the patient using the Edinburgh Hypoglycemia Symptom Scale (EHSS) and are accompanied by a decrease in blood glucose levels within the postprandial period as evaluated through the CGMS.

The postprandial period is defined as the 3 hours following meal intake. A minimum blood glucose cut-off value is not required for symptom reporting. Each treatment period spans the 48 hours following study-drug administration (Anakinra or Placebo).
Through the 40-day interventional period

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Time Below Range (TBR)
Időkeret: Through the 40-day interventional period
Time Below Range (TBR): The percentage and total duration of sensor glucose readings below thresholds of 3.3 mmol/L, 3.0 mmol/L, and 2.7 mmol/L during Anakinra treatment compared to placebo, assessed using cumulative data from all 48-hour treatment periods (48 hours following study-drug administration, Anakinra or Placebo).
Through the 40-day interventional period
Time in hyperglycaemia
Időkeret: Through the 40-day interventional period
Time in hyperglycaemia: The percentage and total duration of sensor glucose readings above 10 mmol/L during Anakinra treatment compared to Placebo, assessed using cumulative data from all 48-hour treatment periods (48 hours following study-drug administration, Anakinra or Placebo).
Through the 40-day interventional period
Pattern of Sensor Glucose
Időkeret: Through the 40-day interventional period
Pattern of Sensor Glucose: The slope of postprandial glucose measurements calculated as the maximal rate of increase and decrease of glucose levels observed over 20 minutes in the postprandial period, compared between Anakinra treatment and placebo, based on data from all 48-hour treatment periods (48 hours following study-drug administration, Anakinra or Placebo). The postprandial period is defined as the 3 hours following meal intake.
Through the 40-day interventional period
Comparison of Glycemic Variability and Extremes Between Interventional and Screening Period
Időkeret: From screening at Day -14 through the 40-day interventional period
Comparison of the entire interventional period with the screening period regarding to the following parameters as defined above: Time Below Range, Time in hyperglycaemia, Pattern of Sensor Glucose, and Mean Amplitude of Glucose Excursions.
From screening at Day -14 through the 40-day interventional period
Effect of Anakinra vs. Placebo on Glycemic and Hormonal Responses During Mixed Meal Tolerance Test
Időkeret: Immediately after Mixed-meal tolerance test

Changes following treatment with Anakinra compared to placebo during a Mixed Meal Tolerance Test in the AUC, peak and nadir values, and slopes of:

  • Glucose
  • Insulin
  • c-peptide
  • GLP-1
  • Glucagon
  • Cortisol
Immediately after Mixed-meal tolerance test
Changes in Fasting Metabolic and Inflammatory Biomarkers After the Interventional Period Compared to Baseline
Időkeret: Through the 40-day interventional period
Changes following the entire interventional period in levels of fasting insulin, c-peptide, glucagon, HbA1c, IL-1Ra, IL-6, TNF-a, IL-18 and hsCRP as compared to Baseline.
Through the 40-day interventional period
Comparison of Prevalence and Severity of Postprandial Hypoglycemia Symptoms Between the Interventional and Screening Periods
Időkeret: From screening at Day -14 through the 40-day interventional period

Prevalence and severity of postprandial hypoglycaemia symptoms during the whole interventional period compared to the Screening period.

Post-prandial hypoglycaemia symptoms and their severity will be evaluated by the patient using the Edinburgh Hypoglycemia Symptom Scale (EHSS) and are accompanied by a decrease in blood glucose levels within the postprandial period as evaluated through the CGMS.

The postprandial period is defined as the 3 hours following meal intake. A minimum blood glucose cut-off value is not required for symptom reporting.-Each treatment period spans the 48 hours following study-drug administration (Anakinra or Placebo).
From screening at Day -14 through the 40-day interventional period
Subjective patient's daily preference for treatment period
Időkeret: Through the 40-day interventional period
The patient will be asked to provide feedback on the treatment periods, indicating which study days he found the treatment more tolerable or beneficial. This subjective assessment will take into account factors such as comfort, side effects, and overall experience during the interventional period.
Through the 40-day interventional period
Adverse events of interest
Időkeret: From first dose of anakinra (Visit 4, Day 3) through the 40-day interventional Period and 15-day follow-up period

Adverse events of interest: AEs of interest include adverse events that can be expected during a treatment with Anakinra.

  • Identification of hypersensitivity reaction during the Interventional period.
  • Detection of any infection during the interventional period.
  • Detection of Neutropenia during the interventional period, defined as absolute neutrophil count <1000/mm³.
  • Detection of Thrombocytopenia during the Interventional period, defined as platelet count <100 000/mm³.
From first dose of anakinra (Visit 4, Day 3) through the 40-day interventional Period and 15-day follow-up period
Serious Adverse Events
Időkeret: From screening on Day -14 through the 40-day interventional period and 15-day follow-up period
A Serious Adverse Event (SAE) is classified as any untoward medical occurrence that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
From screening on Day -14 through the 40-day interventional period and 15-day follow-up period

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Marc Donath

Együttműködők

Kantonsspital Baden

Nyomozók

  • Kutatásvezető: Matthias Hepprich, PD Dr. med., University of Basel, Claraspital Basel

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Hasznos linkek

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. július 1.

Elsődleges befejezés (Becsült)

2026. október 1.

A tanulmány befejezése (Becsült)

2026. december 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. március 9.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. május 5.

Első közzététel (Tényleges)

2026. május 12.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. május 12.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. május 5.

Utolsó ellenőrzés

2026. április 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • 2025-00684

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

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