NCT00287183

Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multicenter Study In Patients With Type 2 Diabetes And Persistent Albuminuria To Evaluate The Safety And Efficacy Of A Six Month Regimen Of Orally-Administered TTP488

Completed Phase 2 Last updated 30 September 2009

What this trial tests

Phase 2 trial testing PF-04494700 (TTP488) in Diabetic Nephropathy in 110 participants. Completed in 1 August 2009.

Timeline

1 February 2006

Primary endpoint
1 August 2009

1 August 2009

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	110
Start date	1 February 2006
Primary completion	1 August 2009
Estimated completion	1 August 2009
Sites	19 locations across Canada

Drugs / interventions tested

• PF-04494700 (TTP488) — full drug profile →
• Placebo

Conditions studied

• Diabetic Nephropathy — all drugs for Diabetic Nephropathy →

Sponsor

Pfizer — full company profile →

Who can join

31 and older, any sex, with Diabetic Nephropathy. 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.

• Primary endpoint of efficacy will be assessed by comparing the treatment groups based on the change in urinary albumin-creatinine ratio (UACR)
  Time frame: from baseline to end of treatment (Month 6).

Sponsor's own description

Current research indicates that TTP488 may be a viable agent for the treatment of diabetic nephropathy. The purpose of this study is to determine the safety and efficacy of a six-month regimen of daily orally-administered TTP488 to patients with diabetic nephropathy.

Publications & conference data

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

1. The New Biology of Diabetic Kidney Disease-Mechanisms and Therapeutic Implications.
   Lytvyn Y, Bjornstad P, van Raalte DH, Heerspink HL, et al · · 2020 · cited 108× · PMID 31633153 · DOI 10.1210/endrev/bnz010
2. Is RAGE still a therapeutic target for Alzheimer's disease?
   Deane RJ. · · 2012 · cited 63× · PMID 22571615 · DOI 10.4155/fmc.12.51
3. Horizon 2020 in Diabetic Kidney Disease: The Clinical Trial Pipeline for Add-On Therapies on Top of Renin Angiotensin System Blockade.
   Perez-Gomez MV, Sanchez-Niño MD, Sanz AB, Martín-Cleary C, et al · · 2015 · cited 51× · PMID 26239562 · DOI 10.3390/jcm4061325
4. IL-1β, RAGE and FABP4: targeting the dynamic trio in metabolic inflammation and related pathologies.
   Hardaway AL, Podgorski I. · · 2013 · cited 39× · PMID 23795967 · DOI 10.4155/fmc.13.90
5. Targeting RAGE to prevent SARS-CoV-2-mediated multiple organ failure: Hypotheses and perspectives.
   Chiappalupi S, Salvadori L, Vukasinovic A, Donato R, et al · · 2021 · cited 28× · PMID 33636175 · DOI 10.1016/j.lfs.2021.119251
6. Prioritization of potential drug targets for diabetic kidney disease using integrative omics data mining and causal inference.
   Zhang J, Peng J, Yu C, Ning Y, et al · · 2025 · cited 3× · PMID 40979545 · DOI 10.1016/j.jpha.2025.101265
7. A Cross-Tissue Transcriptome-Wide Association Study Identifies Novel Susceptibility Genes for Glomerular Diseases.
   Mao L, Xu L, Zhu T, Liu X, et al · · 2026 · PMID 42193397 · DOI 10.3390/biomedicines14051072