NCT02474667

A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of ANG-3777 (Formerly BB3) to Improve Graft Function and Reduce the Severity of Kidney Dysfunction or Delayed Graft Function Following Kidney Transplantation in Recipients of a Deceased Donor Kidney

Status unknown Phase 3 Last updated 1 June 2021

What this trial tests

Phase 3 trial testing ANG-3777 in Delayed Graft Function in 253 participants. Status unknown.

Timeline

1 March 2016

Primary endpoint
1 September 2021

1 September 2021

Quick facts

Lead sponsor	Angion Biomedica Corp
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	253
Start date	1 March 2016
Primary completion	1 September 2021
Estimated completion	1 September 2021
Sites	30 locations across United States

Drugs / interventions tested

• ANG-3777 — full drug profile →
• Placebo

Conditions studied

• Delayed Graft Function — all drugs for Delayed Graft Function →

Sponsor

Angion Biomedica Corp — full company profile →

Who can join

18 and older, any sex, with Delayed Graft Function. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The severity of DGF
  Time frame: Day 360
  The primary endpoint is renal function assessed by eGFR (using the CKD-EPI equation based on serum creatinine), with a primary analysis time point consisting of eGFR at month 12.

Sponsor's own description

The major objective is to demonstrate the safety and efficacy of ANG-3777 in improving graft function and reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased donor renal allograft.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Perioperative Acute Kidney Injury.
   Gumbert SD, Kork F, Jackson ML, Vanga N, et al · · 2020 · cited 209× · PMID 31687986 · DOI 10.1097/aln.0000000000002968
2. New drugs for acute kidney injury.
   Pickkers P, Murray PT, Ostermann M. · · 2022 · cited 33× · PMID 35999470 · DOI 10.1007/s00134-022-06859-y
3. Acute kidney injury: emerging pharmacotherapies in current clinical trials.
   Benoit SW, Devarajan P. · · 2018 · cited 33× · PMID 28601936 · DOI 10.1007/s00467-017-3695-3
4. Acute Kidney Injury (AKI) before and after Kidney Transplantation: Causes, Medical Approach, and Implications for the Long-Term Outcomes.
   Palmisano A, Gandolfini I, Delsante M, Cantarelli C, et al · · 2021 · cited 26× · PMID 33918444 · DOI 10.3390/jcm10071484
5. Medical Therapies to Reduce Delayed Graft Function and Improve Long-Term Graft Survival: Are We Making Progress?
   Lim MA, Bloom RD. · · 2020 · cited 21× · PMID 31911413 · DOI 10.2215/cjn.13961119
6. Phase 3 trial Design of the Hepatocyte Growth Factor Mimetic ANG-3777 in Renal Transplant Recipients With Delayed Graft Function.
   Vincenti F, Kim J, Gouveia D, Pelle G, et al · · 2021 · cited 12× · PMID 33615054 · DOI 10.1016/j.ekir.2020.11.001
7. The Growth Factors: Potential Biomarkers and Therapeutic Targets in Kidney Diseases.
   Tang W, Zhang Y, Cui S, Yi F. · · 2022 · cited 3× · PMID 36466071 · DOI 10.1159/000526208
8. The therapeutic horizon of acute kidney injury in critical care: exploring pathology, promises, pitfalls, and progress.
   Vogelaar Y, Mourisse L, Pickkers P. · · 2025 · PMID 41191836 · DOI 10.1097/mcc.0000000000001331