PRODIG : Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early post-transplant period

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional Universitaire

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Metabolism [G03]

Trial duration

13 Aug 2024 → ongoing

Decision date (initial)

2024-08-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

PHRC National 2015

External identifiers

EU CT number

2024-516272-14-00

EudraCT number

2016-002023-28

ClinicalTrials.gov

NCT02849899

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

to demonstrate that a short term treatment of vildagliptin administered in the early post-transplant period prevents the occurrence of post-transplant diabetes one year after kidney transplantation.

Secondary objectives 4

1. to determine the effect of vildaglipin administration on glycemic control (glycosylated hemoglobin) at 3, 6 and 12 months after transplantation
2. the occurrence of acute rejection and infections 1 year after transplantation
3. correlation with the health-related quality of life (ReTRANSQOL questionnaire), 8 days, 3 months, 6 months and 12 months after transplantation.
4. the cost-effectiveness ratio will be analyzed in both groups of patients.

Conditions and MedDRA coding

renal transplant

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patient receiving a first kidney transplant
2. Patients considered at high risk of developing posttransplant diabetes having at least 2 of the 3 following criteria: Age> 50 years; BMI greater than 30 kg/m²; Direct Family history of type 2 diabetes
3. Patients who can receive immunosuppressive therapy including tacrolimus, mycophenolic acid and steroids
4. Patients in whom the cessation of steroids may be considered at the latest at Month 3 post-transplant

Exclusion criteria 7

1. Hepatic insufficiency
2. Patient with Class IV NYHA Heart Failure
3. Patient with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome
4. Active infection
5. Infection with Hepatitis C virus
6. Multi-Organ Transplantation
7. A history of diabetes / pancreatitis /angioedema

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. the proportion of diabetic patients 1 year after transplantation, defined as one of the following proposals: - Patients receiving a diabetic treatment - Patients have a fasting glucose above 7 mmol/l - Patients with an abnormal oral glucose tolerance test (OGTT)

Secondary endpoints 4

1. The glycated hemoglobin (HbA1c) 3 months, 6 months and 12 months after transplantation and Laboratory tests (creatinine, creatinine clearance, uric acid, CRP, lipid profile, blood sugar, liver and pancreas balance, blood count) 3 months, 6 months and 12 months after transplantation
2. The occurrence of acute rejection, infection, graft loss and patient death 3 months, 6 months and 12 months after transplantation,
3. The health related quality of life (ReTRANSQOL questionnaire) 8 days, 3 months, 6 months and 12 months after transplantation compared to the baseline,
4. The cost of the care and treatment up to one year after transplantation.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional Universitaire

Sponsor organisation

Centre Hospitalier Regional Universitaire

Address

2 Place Saint Jacques, Cs 51804 Cs 51804

City

Besancon Cedex

Postcode

25030

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional Universitaire

Contact name

Pr Didier DUCLOUX

Public contact point

Organisation

Centre Hospitalier Regional Universitaire

Contact name

Pr Didier DUCLOUX

Locations

1 EU/EEA country · 9 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 6 files

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

Application history

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