PROMISE

Start 16 May 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 4 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Ongoing, recruiting

Participants planned 44

Countries 1

Sites 4

Chronic kidney disease

To demonstrate that patiromer, compared with placebo, better enables up-titration of RAAS-blocker treatment in patients with CKD stage 3b/4, resulting in a significant reduction in albuminuria.

Key facts

Sponsor: University Medical Center Groningen
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18], Diseases [C] - Cardiovascular Diseases [C14]
Trial duration: 16 May 2024 → ongoing
Decision date (initial): 2024-01-26
Transition trial: No
Low-intervention: Yes
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To demonstrate that patiromer, compared with placebo, better enables up-titration of RAAS-blocker treatment in patients with CKD stage 3b/4, resulting in a significant reduction in albuminuria.

Secondary objectives 1

The main secondary endpoint is systolic and diastolic blood pressure, assessed by a 24-hour ambulatory blood pressure measurement at the end of each study period. Further secondary endpoints are plasma potassium levels, kidney function, as reflected by the estimated glomerular filtration rate (eGFR) using the combined cystatin C-creatinine-based CKD-EPI formula, the achieved irbesartan dose and the number of (severe) adverse events at the end of each study period.

Conditions and MedDRA coding

Chronic kidney disease

Regulatory references

Plan to share IPD: No

EU CT number	Title	Sponsor
2023-505626-34-00	PROMISE: Potassium correction for RAAS Optimization in Chronic Kidney Disease	University Medical Center Groningen

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

Age ≥ 18 years; CKD stage 3b-4 (eGFR 15-44 mL/min/1.73 m2 - Albumin-creatinine ratio >3 mg/mmol - Systolic blood pressure >130 mmHg or use of one or more antihypertensive drugs; Serum K+ 4.0-5.0 mmol/L; On sub-maximal dose ACEi/ARB

Exclusion criteria 1

Prior ACEi/ARB dose reduction due to a drop in eGFR by >25% in the last year; history of severe hyperkalaemia (>6.0 mmol/L) in the last year; pregnancy or breastfeeding; life expectancy <12 months

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

The main trial endpoint is 24-hour urinary albumin excretion, adjusted for creatinine (albumin-creatinine ratio, ACR), at the end of each study period.

Secondary endpoints 1

The main secondary endpoint is systolic and diastolic blood pressure, assessed by a 24-hour ambulatory blood pressure measurement at the end of each study period. Further secondary endpoints are plasma potassium levels, kidney function, as reflected by the estimated glomerular filtration rate (eGFR) using the combined cystatin C-creatinine-based CKD-EPI formula, the achieved irbesartan dose and the number of (sever) adverse events at the end of each study period.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

—

SCP25147231 · ATC

Route of administration: ORAL
Max daily dose: 25.2 g gram(s)
Max total dose: 25.2 g gram(s)
Max treatment duration: 12 Week(s)
Authorisation status: Authorised
ATC code: V03AE09 — PATIROMER CALCIUM
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Placebo 1

microcrystalline cellulose and xanthan gum

N/A · Product

Other product name: N/A
Pharmaceutical form: N/A
ATC code: N/A — N/A
Marketing authorisation: N/A
MA holder: N/A
MA country: Iceland
Paediatric formulation: No

Auxiliary 1

Hydrochlorothiazide

SCP144473 · ATC

Active substance: Hydrochlorothiazide
Route of administration: ORAL
Max daily dose: 300 mg milligram(s)
Max total dose: 300 mg milligram(s)
Max treatment duration: 12 Week(s)
Authorisation status: Authorised
ATC code: C09CA04 — IRBESARTAN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Medical Center Groningen

Sponsor organisation: University Medical Center Groningen
Address: Hanzeplein 1
City: Groningen
Postcode: 9713 GZ
Country: Netherlands

Scientific contact point

Organisation: University Medical Center Groningen
Contact name: Prof. M.H. de Borst

Public contact point

Organisation: University Medical Center Groningen
Contact name: Prof. M.H. de Borst

Locations

1 EU/EEA country · 4 investigational sites

By country

Country	MS status	Planned subjects	Sites
Netherlands	Ongoing, recruiting	44	4
Rest of world	—	0	—

Investigational sites

Netherlands

4 sites · Ongoing, recruiting

Isala Klinieken Stichting

Nephrology, Dokter Van Heesweg 2, 8025 AB, Zwolle

Amsterdam UMC

Nephrology, De Boelelaan 1117, 1081 HV, Amsterdam

Medisch Centrum Leeuwarden B.V.

Nephrology, Henri Dunantweg 2, 8934 AD, Leeuwarden

Universitair Medisch Centrum Groningen

Nephrology, Hanzeplein 1, 9713 GZ, Groningen

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Netherlands	2024-05-16		2024-06-19

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_ Protocol 2023-505626-34-01	2.1
Recruitment arrangements (for publication)	K1_ Recruitment arrangements	1.1
Subject information and informed consent form (for publication)	L1_ SIS and ICF Adults	2.0
Summary of Product Characteristics (SmPC) (for publication)	G2_ SmPC patiromer	2.0
Synopsis of the protocol (for publication)	D1_ Protocol synopsis_ENG 2023-505626-34-01	2.0
Synopsis of the protocol (for publication)	D1_ Protocol synopsis_NL 2023-505626-34-01	2.1

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-10-26	Netherlands	Acceptable 2024-01-26	2024-01-26
2	SUBSTANTIAL MODIFICATION	SM-1	2025-03-27	Netherlands	Acceptable 2025-05-12	2025-05-12
3	SUBSTANTIAL MODIFICATION	SM-2	2025-11-21	Netherlands	Acceptable 2025-12-12	2025-12-12

Promise