RAN BioLinks to support the AGREE clinical trial

Wednesday, January 10, 2024

Exciting News from RAN BIOLINKS!

As we embark on a new year, I am thrilled to announce a significant milestone for our team. The maternal-infant clinical trial (AGREE) managed by RAN BIOLINKS from data perspective has officially commenced the enrolment of participants and has already collected nearly 400 samples within just 10 days!

The AGREE (L-ArGinine to pRevent advErse prEgnancy Outcomes) trial aims to recruit 2,960 pregnant Kenyan women who will be randomly assigned to either a twice-daily dietary supplement containing L-citrulline (converted in amino acid L-arginine) or a placebo supplement. L-arginine plays a vital role in placental development and function, but protein undernutrition in low-resource settings often leads to its deficiency, increasing the risk of adverse pregnancy outcomes (fetal loss (miscarriage or stillbirth), preterm birth, low birth weight, small for gestational age, or neonatal mortality).

The current objective of AGREE trial is to investigate if daily oral supplementation of L-citrulline, efficiently converted to L-arginine, can reduce adverse pregnancy outcomes in high-risk pregnant women in Kenya, particularly those at risk of malaria and protein undernutrition.

Maternal participants will be diligently monitored every month until delivery, with additional follow-ups at weeks 1 and 6 after birth. Infants will also be closely followed up at ages 6, 12, 18, and 24 months.

The results of this groundbreaking study hold the potential to guide obstetric and public health policy, offering a sustainable solution that could be implemented at the community level.

As a pivotal player in this initiative, RAN BIOLINKS is taking on a crucial role in supporting the study through:

* Data Platform: We've implemented a robust data platform to ensure seamless sample tracking, providing real-time insights to enhance the efficiency and accuracy of the study.
* Team Training: Our team has conducted comprehensive training sessions to empower and equip the study's workforce with the necessary skills and knowledge to execute the trial successfully.
* Participants Kits Manufacturing: RAN BIOLINKS is actively involved in the manufacturing standardized participants' kits in collaboration with MARKEN KIT building in Germany ensuring the consistent and high-quality delivery of essential materials for the study.

This multifaceted support system is geared towards maximizing the impact of the AGREE trial. We're dedicated to facilitating a smooth and successful execution, ultimately contributing to advancements in obstetric and public health policies.

For more information about the trial please visit ClinicalTrials.gov


Our Services Make A Difference, Hear It From Our Collaborators

"More than a Thousand households enrolled in record time and followed up throughout the study with home visits (in the midst of lockdowns) is what I would call LARGE SCALE!"

I know that most studies (even before the COVID, but especially during the pandemic) took years between starting and locking down data (and that is not taking into account the actual study duration). The operational infrastructure that you enabled for ConCorD19 was the first time that all of us PIs were part of a study that was implemented within weeks of design and data locked down within a few weeks of study end. This is unprecedented in my experience

- Prof. Tobias Kollmann
​Professor of System Vaccinology

"The day to day logistics of every aspect of the trial were managed, including procurement of the necessary biospecimen collection kits and transportation supplies"

Our COVID-19 clinical trial required coordination of field teams, timed biospecimen collection and the processing, storage and transportation of clinical samples (across international borders). The management of data that accrued in the trial database in real time ensured that the protocol was adhered to and provided the principle investigators tools to follow participant registration and biospecimen collection. In every regard, the operational needs of the trial were facilitated by RAN BioLinks. The day to day logistics of every aspect of the trial were managed, including procurement of the necessary biospecimen collection kits and transportation supplies, securing regulatory approvals for biospecimen transfers and coordinating border and customs requirements to expedite transfers. I look forward to working with RAN BioLinks in the future.

- Prof. Eleanore Fish
Professor & Associate Chair
Dept. Immunology, University of Toronto

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