MK-2060 Global Study in Patients with End Stage Renal Disease Receiving Hemodialysis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

25 Nov 2021 → 13 Feb 2025

Decision date (initial)

2024-07-12

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2024-511055-17-00

EudraCT number

2020-002397-27

WHO UTN

U1111-1303-0286

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Pharmacodynamic, Safety

1.To evaluate the efficacy of MK-2060 compared to placebo in increasing the time to first arteriovenous graft thrombosis event.

Secondary objectives 2

1. To evaluate the efficacy of MK-2060 compared to placebo in increasing the time to each arteriovenous graft thrombosis event (first and recurrent).
2. To assess the safety and tolerability of MK-2060.

Conditions and MedDRA coding

Prevention of arteriovenous graft thrombosis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Current diagnosis of ESRD.
2. Receiving hemodialysis (including hemodiafiltration) ≥3 times per week for a minimum of 3 hours per session via a mature normally functioning, uninfected AVG with at least 75% of the sessions meeting these criteria over the 4 weeks prior to randomization
3. A female participant is not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance during the intervention period and for at least 90 days after the last dose of study intervention.

Exclusion criteria 8

1. Recent history of cancer (<1 year). Non-melanoma skin cancers are allowed.
2. Mechanical/prosthetic heart valve.
3. Recent hemorrhagic stroke or lacunar stroke (<1 month).
4. Recent evidence (<1 month) of bleeding requiring hospitalization or unplanned medical attention, a history (≤2 years) of recurrent bleeding episodes including epistaxis, gastrointestinal (GI) bleeds or genitourinary (GU) bleeds requiring medical treatment or events requiring treatment with blood products.
5. Recent history (<1 year) of drug or alcohol abuse or dependence.
6. Currently receiving or planning to receive anticoagulants or antiplatelet medications (intradialytic heparin and aspirin are permitted).
7. Planning on receiving a living donor renal transplant within 12 months (participants are permitted to be candidates for deceased donor renal transplants).
8. Planning on receiving an arteriovenous fistula (AVF) placement within 12 months.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time to First AVG Thrombosis Event

Secondary endpoints 4

1. Time to Each Arteriovenous Graft Thrombosis Event (First and Recurrent)
2. Number of Participants who Experience One or More Adverse Events (AEs)
3. Number of Major Bleeding Events or Clinically Relevant Non-Major Bleeding Events per International Society on Thrombosis (ISTH) Criteria
4. Number of Participants Who Discontinue Study Intervention Due to an AE

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Brandon Atkins

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Brandon Atkins

Third parties 9

Locations

8 EU/EEA countries · 20 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 38 files

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

Application history

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