Revealing Engagement Dynamics Among Diabetic Kidney Disease Patients

NCT ID: NCT06101901

Last Updated: 2023-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-30

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Kidney Disease

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Power Life Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Gill

Role: STUDY_DIRECTOR

Power Life Sciences Inc.

Locations

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Power Life Sciences

San Francisco, California, United States

Site Status

Countries

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United States

Central Contacts

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Michael B Gill

Role: CONTACT

(415) 900-4227

References

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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.

Reference Type BACKGROUND
PMID: 33122288 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32135136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33797560 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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63894857

Identifier Type: -

Identifier Source: org_study_id

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