NCT06101901

Brief Summary

The study intends to investigate the personal experiences of diabetic kidney disease patients who take part in a separate clinical study including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal. The data collected from this study will help improve future outcomes for all diabetic kidney disease as well as those in under-represented demographic groups.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Nov 2024Nov 2026

First Submitted

Initial submission to the registry

October 20, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 20, 2023

Last Update Submit

October 20, 2023

Conditions

Diabetic Kidney Disease

Keywords

diabetic kidney disease

Outcome Measures

Primary Outcomes (2)

  • Number of patients who decide to enroll in a diabetic kidney disease clinical research

    3 months

  • Rate of patients who remain in a diabetic kidney disease clinical trial to trial completion

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with diabetic kidney disease who are actively considering enrolling in a clinical trial for said condition, but have not yet completed enrollment and randomization phases.

You may qualify if:

  • Patients diagnosed with diabetic kidney disease
  • Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
  • Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.

You may not qualify if:

  • Refusal of consent
  • Women of childbearing potential without a negative pregnancy test; or women who are lactating.
  • Any serious and/or unstable pre-existing medical disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

  • Schrauben SJ, Shou H, Zhang X, Anderson AH, Bonventre JV, Chen J, Coca S, Furth SL, Greenberg JH, Gutierrez OM, Ix JH, Lash JP, Parikh CR, Rebholz CM, Sabbisetti V, Sarnak MJ, Shlipak MG, Waikar SS, Kimmel PL, Vasan RS, Feldman HI, Schelling JR; CKD Biomarkers Consortium and the Chronic Renal Insufficiency Cohort (CRIC) Study Investigators. Association of Multiple Plasma Biomarker Concentrations with Progression of Prevalent Diabetic Kidney Disease: Findings from the Chronic Renal Insufficiency Cohort (CRIC) Study. J Am Soc Nephrol. 2021 Jan;32(1):115-126. doi: 10.1681/ASN.2020040487. Epub 2020 Oct 29.

    PMID: 33122288BACKGROUND

  • Tofte N, Lindhardt M, Adamova K, Bakker SJL, Beige J, Beulens JWJ, Birkenfeld AL, Currie G, Delles C, Dimos I, Francova L, Frimodt-Moller M, Girman P, Goke R, Havrdova T, Heerspink HJL, Kooy A, Laverman GD, Mischak H, Navis G, Nijpels G, Noutsou M, Ortiz A, Parvanova A, Persson F, Petrie JR, Ruggenenti PL, Rutters F, Rychlik I, Siwy J, Spasovski G, Speeckaert M, Trillini M, Zurbig P, von der Leyen H, Rossing P; PRIORITY investigators. Early detection of diabetic kidney disease by urinary proteomics and subsequent intervention with spironolactone to delay progression (PRIORITY): a prospective observational study and embedded randomised placebo-controlled trial. Lancet Diabetes Endocrinol. 2020 Apr;8(4):301-312. doi: 10.1016/S2213-8587(20)30026-7. Epub 2020 Mar 2.

    PMID: 32135136BACKGROUND

  • Chan L, Nadkarni GN, Fleming F, McCullough JR, Connolly P, Mosoyan G, El Salem F, Kattan MW, Vassalotti JA, Murphy B, Donovan MJ, Coca SG, Damrauer SM. Derivation and validation of a machine learning risk score using biomarker and electronic patient data to predict progression of diabetic kidney disease. Diabetologia. 2021 Jul;64(7):1504-1515. doi: 10.1007/s00125-021-05444-0. Epub 2021 Apr 2.

    PMID: 33797560BACKGROUND

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Michael B Gill

    Power Life Sciences Inc.

    STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

(415) 900-4227bask@withpower.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2023

First Posted

October 26, 2023

Study Start

November 1, 2024

Primary Completion

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

October 26, 2023

Record last verified: 2023-10

Locations

US(1)