GLP-1 receptor agonists as preventive treatment of diabetes after renal transplantation: a single-arm interventional clinical trial. Study 2: Patients on the waiting list for kidney transplantation.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bellvitge University Hospital, Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

22 Mar 2024 → 31 Mar 2026

Decision date (initial)

2023-12-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

To evaluate whether 3 to 6 months treatment with GLP-1 RA in patients on the RT waiting list with metabolic syndrome (defined by meeting 2 or more criteria of: prediabetes, abdominal obesity, hypertriglyceridemia and/or dyslipidemia) reverse metabolic syndrome before RT - evaluating the status after 3 and 6 months after having started the medication - (reversing the metabolic syndrome) after 3 and, if possible, 6 months of treatment.

Secondary objectives 4

1. Insulin sensitivity
2. Changes in abdominal obesity (change in waist circumference index and waist-hip circumference)
3. Treatment safety by recording adverse reactions, rate of discontinuations
4. Appearance of post-transplant diabetes

Conditions and MedDRA coding

Metabolic syndrome in patients on the waiting list for kidney transplantation

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients on the RT waiting list
2. Over 18 years
3. Women of childbearing potential must use effective contraceptive measures during their participation in the study.
4. With metabolic syndrome defined by 2 or more of the following criteria (National Cholesterol Education Program Adult Treatment Panel III guidelines (7) adjusted for: (a) pre-diabetes as determined by:  fasting plasma glucose of 100-126 mg/dL (5.6-6.9 mmol/L ),  and/or impaired fasting glucose <126 mg/dL (7 mmol/L) with 2 h plasma glucose after an oral glucose of 140-200 mg/dL (7.8-11 mmol/L)  and/or HbA1c 5.7-6.4%) (b) obesity as defined by: waist circumference greater than 102 cm (men) or 88 cm (women) c) triglycerides ≥150 mg/dL d) HDL cholesterol < 40mg/dL in men or < 50mg/dL in women

Exclusion criteria 8

1. Under 18 years of age,
2. previously diagnosed diabetes,
3. Hepatic Failure
4. history of pancreatitis (acute or chronic),
5. síndrome de neoplasia endocrina múltiple tipo 2 (MEN 2)
6. personal or family history of medullary thyroid carcinoma (MTC),
7. pregnant or lactating women
8. moderate to severe pre-existing gastroparesis.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients with reversal of metabolic syndrome after 3 and 6 months of GLP1RA initiation defined by correction of metabolic syndrome (must be reduced to 1 or less defining criteria) by: (a) correction of pre-diabetes as determined by:  fasting plasma glucose of 100-126 mg/dL (5.6-6.9 mmol/L),  and/or impaired fasting glucose of <126 mg/dL (7 mmol/L) with 2 h plasma glucose after an oral glucose of 140-200 mg/dL (7.8-11 mmol/L)

Secondary endpoints 4

1. Insulin sensitivity as measured by assessment of the homeostatic model calculated for insulin resistance score (HOMA-IR) and β-cell function as measured by the HOMA index of β-cell function (HOMA-B) at study inclusion, 3 and 6 months after initiation of therapy.
2. Adverse Reactions: Gastrointestinal (nausea or diarrhea), pancreatitis, headaches, injection site pain, weakness, and severe hypoglycemic episodes defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or take other corrective measures), rate of treatment discontinuation at 3 and 6 months after initiation of therapy.
3. Changes in abdominal obesity (waist circumference and change in waist-hip ratio since enrollment in the study, at 3 and 6 months after the start of therapy).
4. Rate of treatment interruptions

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bellvitge University Hospital

Sponsor organisation

Bellvitge University Hospital

Address

Carrer De La Feixa Llarga Sn

City

L'hospitalet De Llobregat

Postcode

08907

Country

Spain

Scientific contact point

Organisation

Bellvitge University Hospital

Contact name

Núria Montero

Public contact point

Organisation

Bellvitge University Hospital

Contact name

Núria Montero

Third parties 1

Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

Sponsor organisation

Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

Address

Avinguda De La Gran Via De L'hospitalet 199

City

L'Hospitalet De Llobregat

Postcode

08908

Country

Spain

Scientific contact point

Organisation

Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

Contact name

Yaiza Hermoso Gallego

Public contact point

Organisation

Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

Contact name

Yaiza Hermoso Gallego

Sponsor responsibilities

Article 77 compliance

Bellvitge University Hospital

Contact point sponsor

Bellvitge University Hospital

Article 77 implementation

Bellvitge University Hospital

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications